A Healthesystems publication

MedMonitor

An up-to-date timeline of U.S. Food and Drug Administration (FDA) approvals that could potentially impact workers' compensation. These include new drug and indication approvals, new dosages or formulations of existing products, and generics introduced to the market. Click through the interactive timeline below, or select the comprehensive list view.

Medication Name Projected Release Category Description
Dsuvia™ (sufentanil) Nov 2018 Pain An opioid analgesic 5-10x stronger than fentanyl. For use in medically supervised healthcare settings for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Note: NEW PRODUCT/INDICATION
Hyrimoz™ (adalimumab-adaz) Oct 2018 Rheumatoid Arthritis Indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ulcerative arthritis, and plaque psoriasis | *This drug is a biosimilar of Humira® (adalimumab)
Note: NEW PRODUCT/INDICATION
Ajovy™ (fremanezumab-vfrm) injection Sep 2018 Migraine A once monthly or quarterly treatment for the prevention of migraines
Note: NEW PRODUCT/INDICATION
Emgality™ (galcanezumab-gnlm) injection Sep 2018 Migraine For the preventive treatment of migraines
Note: NEW PRODUCT/INDICATION
Brilinta® (ticagrelor) tablets Sep 2018 Cardiovascular For post-acute coronary syndrome management
Note: FIRST-TIME GENERIC
Cassipa® (buprenorphine and naloxone) sublingual film Sep 2018 Opioid Dependence A new dosage for the maintenance treatment of opioid dependence
Note: NEW DOSAGE/FORMULATION
Inveltys™ (loteprednol etabonate ophthalmic suspension) 1% Aug 2018 Pain A topical corticosteroid for the treatment of postoperative inflammation and pain following ocular surgery
Note: NEW PRODUCT/INDICATION
Pifeltro™ (doravirine) tablets Aug 2018 HIV Indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients with no prior antiretroviral treatment
Note: NEW PRODUCT/INDICATION
Delstrigo™ (doravirine, lamivudine, and tenofovir disoproxil fumarate) tablets Aug 2018 HIV A complete regimen for the treatment of HIV-1 infection in patients with no antiretroviral history
Note: NEW PRODUCT/INDICATION
Emtriva® (emtricitabine) capsules Jul 2018 HIV For the treatment of HIV-1 infection, in combination with other antiretroviral agents
Note: FIRST-TIME GENERIC
Remodulin® (treprostinil) Jul 2018 Pulmonary Arterial Hypertension For the treatment of pulmonary arterial hypertension to reduce symptoms associated with exercise
NOTE: This approval allows Remodulin to be used as part of an implantable pump system
Note: NEW DOSAGE/FORMULATION
Daliresp® (roflumilast) tablets Jul 2018 Chronic Obstructive Pulmonary Disease Indicated to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations
Note: FIRST-TIME GENERIC
Suboxone® (buprenorphine and naloxone) sublingual film Jun 2018 Opioid Dependence For the treatment of opioid dependence
Note: FIRST-TIME GENERIC
Olumiant® (baricitinib) tablets Jun 2018 Rheumatoid Arthritis For the treatment of moderate-to-severe rheumatoid arthritis
Note: NEW PRODUCT/INDICATION
Epidiolex® (cannabidiol) oral solution Jun 2018 Antiepileptic For the treatment of seizures associated with Lennox- Gastaut syndrome or Dravet syndrome
NOTE: The first FDA-approved drug that contains a purified substance derived from marijuana.
Note: NEW PRODUCT/INDICATION
Lucemyra™ (lofexidine) May 2018 Opioid Dependence For mitigation of opioid withdrawal symptoms to facilitate abrupt opioid withdrawal; the first non-opioid drug available to treat opioid withdrawal
Note: NEW PRODUCT/INDICATION
Aimovig™ (erenumab-aooe) injection May 2018 Migraine A once-monthly preventive treatment to reduce the frequency of migraines
Note: NEW PRODUCT/INDICATION
Naropin® (ropivacaine hydrochloride) injection USP Apr 2018 Pain For local/regional surgical anesthesia and acute pain management
Note: FIRST-TIME GENERIC
Trogarzo™ (ibalizumab-uiyk) intravenous injection Mar 2018 HIV For patients who have tried multiple HIV drugs and can’t be successfully treated with other available therapies
Note: NEW PRODUCT/INDICATION
Symfi™ (efavirenz, lamivudine and tenofovir disoproxil fumarate) oral tablets Mar 2018 HIV A complete regimen for HIV type 1 infection
Note: NEW PRODUCT/INDICATION
Symfi Lo™ (efavirenz, lamivudine and tenofovir disoproxil) tablets Feb 2018 HIV A complete regimen for individuals with HIV-1 infection, featuring a reduced dose of efavirenz
Note: NEW PRODUCT/INDICATION
Biktarvy® (bictegravir, emtricitabine, and tenofovir alafenamide) tablets Feb 2018 HIV A complete regimen for individuals with HIV-1 infection who have no antiretroviral treatment history, or to replace current antiretroviral regimens in individuals who are virologically suppressed
Note: NEW PRODUCT/INDICATION
Apadaz™ (benzhydrocodone acetaminophen) oral tablets Feb 2018 Pain A prodrug opioid indicated for short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic
Note: NEW PRODUCT/INDICATION
ZTlido™ (lidocaine topical system) 1.8% Feb 2018 Pain For the relief of pain associated with post-herpetic neuralgia (after-shingles pain)
Note: NEW PRODUCT/INDICATION
Cimduo™ (lamivudine/tenofovir disoproxil fumarate) tablets Feb 2018 HIV Approved in combination with other antiretrovirals for the treatment of HIV-1 infection
Note: NEW PRODUCT/INDICATION
Viread® (tenofovir disoproxil fumarate) tablets Jan 2018 HIV Indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Also indicated for the treatment for chronic hepatitis B
Note: FIRST-TIME GENERIC
Sustiva® (efavirenz) capsules Dec 2017 HIV For the treatment of HIV-1 infection
Note: FIRST-TIME GENERIC
Lonhala™ Magnair™ (glycopyrrolate) inhalation solution Dec 2017 COPD For long-term maintenance of chronic obstructive pulmonary disease
Note: NEW PRODUCT/INDICATION
Prexxartan® (valsartan) oral solution Dec 2017 Cardiovascular For treatment of high blood pressure and heart failure; oral solution indicated for patients unable to swallow valsartan tablets
Note: NEW PRODUCT/INDICATION
Repatha® (evolocumab) injection Dec 2017 Cardiovascular Now indicated to reduce risk for cardiovascular (CV) events in patients with established CV disease
Note: NEW PRODUCT/INDICATION
Sublocade™ (buprenorphine) injection Nov 2017 Opioid Dependence Once-monthly injectable for moderate-to-severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine product
Note: NEW PRODUCT/INDICATION
Tekturna® (aliskiren) oral pellets Nov 2017 Cardiovascular For the treatment of hypertension to lower blood pressure
Note: NEW DOSAGE/FORMULATION
Juluca (dolutegravir/rilpivirine) Nov 2017 HIV For HIV-1 infection, to replace antiretroviral regimens in patients virologically suppressed for at least six months
Note: NEW PRODUCT/INDICATION
Prezista® (darunavir ethanolate) tablets Nov 2017 HIV For the treatment of HIV-1 infection
Note: FIRST-TIME GENERIC
Zilretta™ (triamcinolone acetonide extended-release injectable suspension) for intra-articular use Oct 2017 Osteoarthritis For the management of osteoarthritis pain of
Lyrica® CR (pregabalin) extended-release tablets Oct 2017 Pain New, once-daily formulation for neuropathic pain associated with diabetic peripheral neuropathy
Durolane® (hyaluronic acid) injection Sep 2017 Osteoarthritis For joint lubrication in the treatment of pain associated with osteoarthritis of the knee
Fiasp® (insulin aspart injection) Sep 2017 Diabetes Indicated to improve glycemic control in adults
Mavyret™ (glecaprevir and pibrentasvir) tablets Aug 2017 Hepatitis C For the treatment of chronic HCV genotypes 1-6. This is the first HCV treatment approved for all HCV genotypes with an eight-week duration
Nikita™ (pitavastatin sodium) tablets Aug 2017 Cardiovascular For hyperlipidemia or mixed dyslipidemia as an adjunct to diet to reduce elevated cholesterol
Cyltezo™ (adalimumab-abdm) Aug 2017 Rheumatoid Arthritis Biosimilar to Humira® (adalimumab). Indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, and plaque psoriasis
Epclusa® (sofosbuvir/velpatasvir) tablets Aug 2017 Hepatitis C Originally approved to treat HCV genotypes 1-6,
Vosevi® (sofosbuvir/velpatasvir/voxilaprevir) tablets Jul 2017 Hepatitis C For the treatment of chronic hepatitis C virus
Effient® (prasugrel) tablets Jul 2017 Cardiovascular For the reduction of cardiovascular events in certain patients with acute coronary symptoms
Norvir® (ritonavir) Jun 2017 HIV For the treatment of HIV-1 infection in combination with other retroviral agents. New oral powder formulation that can be mixed into soft food or liquid
Pennsaid® (diclofenac sodium) May 2017 Osteoarthritis For the treatment of osteoarthritis pain of the knee
Bystolic® (nebivolol) tablets May 2017 Cardiovascular For the treatment of hypertension to lower
Truvada® (emtricitabine and tenofovir disoproxil fumarate) tablets May 2017 HIV For the treatment of HIV-1 infection in combination with other antiretroviral agents
Isentress® HD (raltegravir) tablets May 2017 HIV For the treatment of HIV-1 infection in combination with other antiretroviral agents. This new formulation is a 1200 mg once-daily dose, compared to the original twice-daily 600 mg dose
Roxybond™ (oxycodone hydrochloride) tablets Apr 2017 Pain For the management of pain severe enough to require an opioid analgesic for which alternative therapies are inadequate
Technivie™ (ombitasvir, paritaprevir, ritonavir) Mar 2017 Antiviral Indicated in combination with ribavirin for the treatment of patients with genotype 4 chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis
Note: NEW PRODUCT/INDICATION, SPECIALTY
Nipride® RTU (sodium nitroprusside) Mar 2017 Cardiovascular Indicated for the immediate reduction of blood pressure to treat acute heart failure, or to reduce bleeding during surgery
Note: NEW PRODUCT/INDICATION
Symproic® (naldemedine) oral tablets Mar 2017 Opioid Side Effects For the treatment of opioid-induced constipation in adults with chronic noncancer pain
Note: NEW PRODUCT/INDICATION
Qtern® (dapagliflozin and saxagliptin) tablets Feb 2017 Diabetes Adjunct to diet and exercise to improve blood sugar control for type 2 diabetes
Note: NEW PRODUCT/INDICATION
Lonhala™ Magnair™ (glycopyrrolate) inhalation solution Jan 2017 COPD For long-term maintenance of chronic obstructive pulmonary disease
Note: NEW PRODUCT/INDICATION
Arymo™ ER (morphine sulfate) extended-release tablets Jan 2017 Opioid For the treatment of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative therapies are inadequate *Arymo ER was originally formulated to be abusedeterrent, but the FDA decided it cannot be concluded that Arymo ER has physical and chemical properties that are expected to reduce abuse via the oral route.
Note: NEW PRODUCT/INDICATION
Vantrela™ ER (hydrocodone bitartrate) extended-release tablets Jan 2017 Opioid For the treatment of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. Formulated with abusedeterrent properties
Note: NEW PRODUCT/INDICATION
Narcan® nasal spray (naloxone hydrochloride) Jan 2017 Opioid Overdose New 2mg dosage, less potent than the original 4mg dosage. Indicated for use in opioid-dependent patients at risk for severe opioid withdrawal
Note: NEW DOSAGE/FORMULATION
Jardiance® (empagliflozin) Dec 2016 Diabetes New indication to reduce the risk of cardiovascular death in adult patients with type 2 diabetes and cardiovascular disease
Note: NEW PRODUCT/INDICATION
Synjardy® XR (empagliflozin/metformin hydrochloride) extended-release tablets Dec 2016 Diabetes An adjunct to diet and exercise to improve blood sugar in adults with type 2 diabetes who have known cardiovascular disease when empagliflozin and metformin are appropriate
Note: NEW PRODUCT/INDICATION
Kaletra® (lopinavir and ritonavir) oral solution Dec 2016 Antiviral For the treatment of HIV-1 infection in combination with other antiretroviral agents
Note: FIRST-TIME GENERIC, SPECIALTY
Livalo® (pitavastatin calcium) tablets Dec 2016 Cardiovascular An adjunct to diet and exercise to improve cholesterol in patients with hyperlipidemia or mixed dyslipidemia
Note: FIRST-TIME GENERIC
Selzentry® (maraviroc) tablets and Selzentry (maraviroc) oral solution Nov 2016 Antiviral Used in combination for the treatment of CCR5-tropic HIV type 1 infection
Note: NEW PRODUCT/INDICATION, SPECIALTY
Soliqua™ 100/33 (insulin glargine and lixisenatide injection) Nov 2016 Diabetes An adjunct to diet and exercise to improve blood sugar control for type 2 diabetes inadequately controlled by basal insulin or lixisenatide
Note: NEW PRODUCT/INDICATION
Xultophy® 100/3.6 (insulin degludec and liraglutide injection) Nov 2016 Diabetes An adjunct to diet and exercise to improve blood sugar control for type 2 diabetes inadequately controlled by basal insulin or lixisenatide
Note: NEW PRODUCT/INDICATION
Seroquel® XR (quetiapine fumarate) extended-release tablets Nov 2016 Antipsychotic For the treatment of schizophrenia, bipolar disorder, or major depressive disorder as adjunctive therapy with antidepressants
Note: FIRST-TIME GENERIC
Carnexiv™ (carbamazepine) injection for intravenous use Oct 2016 Antiepileptic Indicated as a replacement for oral carbamazepine formulations when oral administration is not feasible to control seizures
Note: NEW PRODUCT/INDICATION
Evzio® (naloxone hydrochloride) autoinjector Oct 2016 Opioid Overdose Used for the emergency treatment of known or suspected opioid overdose. Originally available in 0.4 mg/mL dosage, an NDA was approved for a more concentrated 2 mg dosage
Note: NEW PRODUCT/INDICATION, NEW DOSAGE/FORMULATION
Benicar HCT® (olmesartan medoxomil and hydrochlorothiazide) tablets Oct 2016 Cardiovascular For the treatment of hypertension to lower blood pressure
Note: FIRST-TIME GENERIC
Invokamet® XR (canagliflozin/metformin hydrochloride) extendedrelease tablets Sep 2016 Diabetes Once-daily adjunct to diet and exercise to help control blood sugar levels in adults with type 2 diabetes mellitus
Note: NEW PRODUCT/INDICATION
Amjevita™ (adalimumabatto) injection Sep 2016 Rheumatoid Arthritis A biosimilar to Humira®; for the treatment of multiple inflammatory diseases, including severe rheumatoid arthritis
Note: NEW PRODUCT/INDICATION, SPECIALTY
Ziagen® (abacavir sulfate) oral solution Sep 2016 Antiviral Indicated for the treatment of HIV- 1 infection, in combination with other antiretroviral agents
Note: FIRST-TIME GENERIC, SPECIALTY
Troxyca® ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules Aug 2016 Pain Opioid agonist with abuse-deterrent properties indicated for pain severe enough to require daily, around-theclock, long-term opioid treatment for which alternative therapies are inadequate
Note: NEW PRODUCT/INDICATION
Adlyxin® (lixisenatide) injection Jul 2016 Diabetes Once-daily injection to improve blood sugar control in adults with type 2 diabetes
Note: NEW PRODUCT/INDICATION
Viekira XR™ (dasabuvir, ombitasvir, paritaprevir, and ritonavir) extendedrelease tablets Jul 2016 Antiviral New extended-release tablets for certain patients with hepatitis C genotype 1a or 1b
Note: NEW DOSAGE/FORMULATION, SPECIALTY
Relistor® (methylnaltrexone bromide) tablets Jul 2016 Opioid Side Effects New oral tablets to replace injections for the treatment of opioid-induced constipation (OIC)
Note: NEW DOSAGE/FORMULATION
Exalgo® (hydromorphone HCl) extended-release tablets Jun 2016 Pain Opioid agonist administered once daily to manage moderate to severe pain in patients requiring continuous, around-the-clock analgesia
Note: FIRST-TIME GENERIC
Ofirmev® (acetaminophen) injection Jun 2016 Pain Treats mild to moderate pain, and can treat moderate to severe pain in conjunction with opioids *The generic version of Ofirmev cannot be launched until December 6, 2020, unless special circumstances are met.
Note: FIRST-TIME GENERIC
Epclusa® (sofosbuvir/ velpatasvir) tablets Jun 2016 Antiviral For the treatment of hepatitis C virus genotypes 1-6
Note: NEW PRODUCT/INDICATION, SPECIALTY
Byvalson™ (nebivolol and valsartan) tablets Jun 2016 Cardiovascular For treatment of hypertension to lower blood pressure
Note: NEW PRODUCT/INDICATION
Fenoglide® (fenofibrate) tablets Jun 2016 Cardiovascular Treats a variety of cholesterol disorders
Note: FIRST-TIME GENERIC
Probuphine® (buprenorphine hydrochloride) subdermal implant May 2016 Opioid Dependence Subdermal implant formulation of the partial opioid agonist buprenorphine, for maintenance treatment of opioid dependence
Note: NEW PRODUCT/INDICATION, SPECIALTY
Odefsey® (emtricitabine/ rilpivirine/tenofovir alafenamide) Apr 2016 Antiviral For treatment of HIV type 1 infection
Note: NEW PRODUCT/INDICATION, SPECIALTY
Viekira Pak™ (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) Apr 2016 Antiviral New indication extending treatment without ribavirin to patients with hepatitis C genotype 1b, with or without compensated cirrhosis
Note: NEW PRODUCT/INDICATION, SPECIALTY
Inflectra® (infliximab-dyyb) for injection Apr 2016 Rheumatoid Arthritis A biosimilar to Remicade®; for the treatment of patients with moderate to severe rheumatoid arthritis
Note: NEW PRODUCT/INDICATION, SPECIALTY
Avandaryl® (rosiglitazone maleate and glimepiride) tablets Apr 2016 Diabetes Adjunct to diet and exercise to improve glycemic control in adult type 2 diabetes
Note: FIRST-TIME GENERIC
Crestor® (rosuvastatin calcium) tablets Apr 2016 Cardiovascular Treats a variety of cholesterol disorders
Note: FIRST-TIME GENERIC
Voltaren® (diclofenac sodium) topical gel 1% Mar 2016 Pain Provides relief of pain for osteoarthritis of joints amenable to topical treatment
Note: FIRST-TIME GENERIC
Xeljanz® XR (tofacitnib citrate) extended-release tablets Feb 2016 Rheumatoid Arthritis Treats moderate to severe rheumatoid arthritis (RA) in patients who have had an inadequate response or intolerance to methotrexate
Note: NEW DOSAGE/FORMULATION, SPECIALTY
Glumetza® (metformin extended-release) Feb 2016 Diabetes Adjunct to diet and exercise to improve glycemic control in adult type 2 diabetes
Sustiva® (efavirenz) tablets Feb 2016 Specialty For treatment of HIV type 1 infection
Zipsor® (diclofenac potassium) capsules Feb 2016 Pain Relief of mild to moderate acute pain
Sustiva® (efavirenz) tablets Jan 2016 Antiviral For treatment of HIV type 1 infection
Sustiva® (efavirenz) tablets Jan 2016 Specialty For treatment of HIV type 1 infection
Note: FIRST-TIME GENERIC, SPECIALTY
Zipsor® (diclofenac potassium) capsules Jan 2016 Pain Relief of mild to moderate acute pain
Note: FIRST-TIME GENERIC
Zepatier™ (elbasvir/ grazoprevir) Jan 2016 Antiviral Used with or without ribavirin for chronic hepatitis C (genotype 1 or 4)
Note: NEW PRODUCT/INDICATION, SPECIALTY
Cetylev™ (acetylcysteine) effervescent tablets for oral solution Jan 2016 Acetaminophen Overdose Antidote for acetaminophen overdose indicated to prevent or lessen liver damage after the ingestion of a potentially hepatotoxic quantity of acetaminophen
Note: NEW PRODUCT/INDICATION
Uptravi® (selexipag) Dec 2015 Cardiovascular Treats pulmonary arterial hypertension
Note: NEW PRODUCT/INDICATION, SPECIALTY
Bridion® (sugammadex) injection Dec 2015 Reverses Neuromuscular Blockade For the reversal of temporary paralysis caused by certain neuromuscular-blocking drugs that may be administered during surgery
Note: NEW PRODUCT/INDICATION
Basaglar® (insulin glargine) Dec 2015 Diabetes To improve glycemic control in adults with type 2 diabetes mellitus
Note: NEW PRODUCT/INDICATION, SPECIALTY
Xtampza™ ER (oxycodone) extended-release capsules Nov 2015 Pain Extended-release opioid analgesic formulation for the management of severe pain. Contains abuse-deterrent properties Note: While the FDA has approved Xtampza ER, the drug is now involved in a patent litigation which has delayed release to the market
Note: NEW PRODUCT/INDICATION
Narcan® (naloxone HCI) nasal spray Nov 2015 Opioid Overdose Narcan® (naloxone HCI) nasal spray
Note: NEW PRODUCT/INDICATION
Harvoni® (ledipasvir and sofosbuvir) Nov 2015 Antiviral New indication to treat hepatitis C infections of patients with genotypes 4, 5 and 6, and patients co-infected with HIV
Note: NEW PRODUCT/INDICATION, SPECIALTY
Genvoya® (elvitegravir/ cobicistat/emtricitabine/ tenofovir alafenamide) Nov 2015 Antiviral Complete regimen for treatment in certain patients with HIV-1
Note: NEW PRODUCT/INDICATION, SPECIALTY
Belbuca (buprenorphine HCl) buccal film Oct 2015 Pain Anticipated approval date October 23, 2015. An opioid analgesic buccal film formulation in development for the management of chronic pain
Note: NEW PRODUCT/INDICATION
Vivlodex™ (meloxicam) capsules Oct 2015 Pain Nonsteroidal anti-inflammatory for osteoarthritis or rheumatoid arthritis in adults
Note: NEW PRODUCT/INDICATION
MorphaBond™ (morphine sulfate) extended-release tablets Oct 2015 Pain Extended-release opioid analgesic for treatment of pain severe enough to require daily, around-the-clock, long-term opioid treatment. Contains abuse-deterrent properties
Note: NEW PRODUCT/INDICATION
Praxbind® (idarucizumab) Oct 2015 Cardiovascular First emergency reversal agent for the anticoagulant Pradaxa®
Note: NEW PRODUCT/INDICATION
Lescol XL® (fluvastatin) Sep 2015 Cholesterol To reduce cholesterol as an adjunct to diet
Note: First time generic
Vraylar™ (cariprazine) Sep 2015 Psychiatry For schizophrenia and bipolar disorder in adults
Note: NEW PRODUCT/INDICATION
Repatha™ (evolocumab) injection Aug 2015 Cholesterol For specific patients requiring additional lowering of LDL-C as adjunct with statin therapy and diet
Note: NEW PRODUCT/SPECIALTY
Abilify® (aripiprazole) oral solution Aug 2015 Psychiatry Indications include adjunctive treatment of major depressive disorder
Note: First time generic
Daklinza™ (daclatasvir) Jul 2015 Antiviral For use with Sovaldi® for chronic hepatitis C (genotype 3)
Note: NEW PRODUCT/SPECIALTY
Praluent® (alirocumab) Jul 2015 Cholesterol For specific patients requiring additional lowering of LDL-C as adjunct with statin therapy and diet
Note: NEW PRODUCT/SPECIALTY
Rexulti® (brexpiprazole) Jul 2015 Psychiatry For treatment of schizophrenia or adjunctive therapy to antidepressants in major depressive disorder
Note: NEW PRODUCT/INDICATION
Technivie™ (ombitasvir/ paritaprevir/ritonavir) Jul 2015 Antiviral For use in combination with ribavirin for chronic hepatitis C (genotype 4)
Note: NEW PRODUCT/SPECIALTY
Pristiq® (desvenlafaxine succinate) Jun 2015 Psychiatry For the treatment of major depressive disorder
Note: First time generic
Zetia® (ezetimibe) Jun 2015 Cholesterol Inhibits intestinal cholesterol absorption as an adjunct to diet
Note: First time generic
Intermezzo® (zolpidem tartrate) Jun 2015 Hypnotic For treatment of middle-of-the night awakening/insomnia - NOTE: Schedule IV controlled substance
Note: First time generic, sleep aid category also
PA32540/PA8140 (aspirin/omeprazole) May 2015 Cardiovascular Reduction in stroke and heart attack for patients undergoing previous events
Abilify® (aripiprazole) Apr 2015 Psychiatry An atypical antipsychotic used to treat psychoses and an add-on to antidepressant therapy for major depressive disorder
Zohydro® ER (hydrocodone bitartrate) Apr 2015 Pain Opioid analgesic for severe pain
Note: Due to controversy, drug maker Zogenix submitted a supplemental NDA for a new, harder-to-abuse formulation with anticipated launch in Q2 2015.
Renagel® (sevelamer) Mar 2015 Specialty to reduce phosphate blood levels in patients with chronic kidney disease who receive dialysis
Sustiva® (efavirenz) Mar 2015 Specialty for HIV/AIDS
Opdivo® (nivolumab) IV injection Mar 2015 Oncology New indication to treat patients with advanced squamous non-small cell lung cancer (NSCLC)
Farydak® (panobinostat) Feb 2015 Oncology For treatment of patients with multiple myeloma who have received at least two prior regimens
Dutrebis™ (lamivudine/raltegravir) Feb 2015 Antiviral For combination use with other antiretroviral agents for the treatment of HIV-1 infection
Indomethacin submicron Jan 2015 Pain formulation of an NSAID that has been available since 1965; for mild to moderate acute pain
Note: Anticipate high cost of this version of a 50- year old drug
Namenda® (memantine) Jan 2015 Hypnotic used to treat Alzheimer’s disease
Note: In February 2014, Forest Laboratories announced discontinuation of the brand name 5 and 10mg tablets as August 15, 2014. The oral liquid and newer extended release capsule will remain on the market. Manufacturer’s information available at www.namenda.com
Zohydro® ER (hydrocodone bitartrate) with BeadTek™ Jan 2015 Pain For the management of severe pain; new formulation with abuse-deterrent
Note: Schedule II controlled substance
Prezcobix™ (darunavir/cobicistat) Jan 2015 Antiviral Combination treatment for HIV-1 infection in adult patients with no darunavir resistance-associated substitutions
Evotaz™ (atazanavir/cobicistat) Jan 2015 Antiviral For use in combination with other antiretroviral agents for the treatment of HIV-1 infection
Androgel® 1% (testosterone) Jan 2015 Opioid Side Effects Testosterone replacement
Nexium® (esomeprazole) delayed-release capsules Jan 2015 Antacid Treatment indications include protection from gastric ulcers associated with continuous nonsteroidal anti-inflammatory drug (NSAID) therapy
Norvir® (ritonavir) 100 mg tablets Jan 2015 Antiviral For use in combination with other antiretroviral agents for treatment of HIV-1 infections
Triferic (ferric pyrophosphate citrate) solution Jan 2015 Dialysis Side Effects For the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease
ABT-450/ritonavir + Ombitasvir Dec 2014 Antiviral Oral, fixed-dose combination therapy for chronic hepatitis C (genotype 1) (priority review)
Peramivir Dec 2014 Antiviral IV infusion for treatment of influenza
Ceftolozane/Tazobactam Dec 2014 Anti-infectives For the treatment of complicated urinary infections and complicated intra-abdominal infections
Viekira Pak™ (ombitasvir/paritaprevir/ritonavir; dasabuvir) Dec 2014 Antiviral Oral, fixed-dose combination therapy for chronic hepatitis C (genotype 1)
Dyloject™ (diclofenac sodium) injection Dec 2014 Pain For the management of mild to moderate pain and moderate to severe pain alone or in combination with opioid analgesics
Trezix™ (acetaminophen/caffeine/dihydrocodeine) Dec 2014 Pain For the relief of moderate to moderately severe pain
Note: Schedule III controlled substance
Copaxone® (glatiramer) Nov 2014 Specialty for relapsing-forms of multiple sclerosis
Targiniq™ ER (oxycodone hydrochloride/naloxone hydrochloride) Nov 2014 Pain opioid controlled-release tablets for chronic pain
AVP-825 (sumatriptan) Nov 2014 Pain Fast-acting, dry-powder intranasal form of sumatriptan for treatment of migraine
Copaxone® (glatiramer) Nov 2014 Autoimmune For relapsing forms of multiple sclerosis
Hysingla™ ER (hydrocodone bitartrate) extended-release tablets Nov 2014 Pain For the management of severe pain; abuse-deterrent features
Note: NOTE: Schedule II controlled substance
Lemtrada™ (alemtuzumab) injection Nov 2014 Autoimmune A third-line treatment for patients with relapsing forms of multiple sclerosis
Epivir® (lamivudine) 10 mg/mL oral solution Nov 2014 Antiviral For use in combination with other antiretroviral agents for human immunodeficiency virus type 1 (HIV-1) infection
Symbicort® Oct 2014 COPD a combination inhaler product for COPD and asthma
Taigexyn® (nemonoxacin) Oct 2014 Anti-infectives an antibiotic to treat community-acquired bacterial pneumonia and skin infections (priority review granted)
Harvoni® (ledipasvir/sofosbuvir) Oct 2014 Transplant Oral, fixed-dose combination therapy for chronic hepatitis C (genotype 1)
Symbicort® (budesonide/formoterol) Oct 2014 COPD A combination inhaler product for COPD and asthma
Taigexyn® (nemonoxacin) Oct 2014 Anti-infectives An antibiotic to treat community-acquired bacterial pneumonia and skin infections (priority review granted)
Naloxegol Sep 2014 Opioid Side Effects for opioid-induced constipation
CERC-301 Sep 2014 Psychiatry for major depressive disorder (priority review granted)
Combivent® (albuterol/ipratropium) Sep 2014 COPD a combination inhaler for COPD
Sufentanil sublingual microtablet system (Zalviso) Sep 2014 Pain opioid for in-hospital pain management of moderate-to-severe acute pain
Note: The potential for availability outside of the hospital setting is unknown; If use outside of hospital is allowed, there is a risk for abuse, misuse & diversion.
Movantik® (naloxegol) Sep 2014 Opioid Side Effects For opioid-induced constipation
Place in therapy: May be seen as an alternative to Relistor®; however, should only be tried if traditional constipation therapies fail (e.g., docusate, senna)
Ferric Citrate Sep 2014 Renal To reduce blood phosphate levels in patients with chronic kidney disease who receive dialysis
Place in therapy: May be used as an alternative to standard therapies (e.g., sevelamer carbonate, calcium acetate) to control high phosphate levels in dialysis patients
Belsomra® (suvorexant) Aug 2014 Hypnotic First orexin receptor antagonist for insomnia
Place in therapy: May consider after 1st line therapies such as zolpidem IR or cognitive behavioral therapy (CBT) failure
Note: Note: Schedule IV controlled substance
Zorvolex® (diclofenac) Aug 2014 Pain Osteoarthritis indication added for this oral NSAID
Place in therapy: Should only be considered once other traditional NSAID options have failed, including oral diclofenac tablets; may be considered for step therapy
Plegridy® (peginterferon beta-1a) Aug 2014 Autoimmune For relapsing forms of multiple sclerosis
Place in therapy: Long-acting form of interferon beta-1a given every 2 weeks; may be used for patients with adherence challenges
Dihydroergotamine (Levadex®) inhaler Jul 2014 Pain for acute migraine
Tavaborole Jul 2014 Anti-infectives a topical antifungal product
Targiniq® (oxycodone HCl/naloxone HCl extended release) Jul 2014 Pain Abuse-deterrent opioid analgesic for moderate to severe pain
Place in therapy: May be an opioid option for patients who are at risk for or have a history of opioid abuse and require long-term opioid treatment
Sivextro™ (tedizolid phosphate) Jul 2014 Anti-infectives Antibiotic for acute bacterial skin and skin structure infections
Place in therapy: Alternative to Zyvox and other traditional oral MRSA treatments; benefit is oral administration and lack of resistance
Zydelig™ (idelalisib) Jul 2014 Oncology Oral agent for relapsed chronic lymphocytic leukemia (CLL), relapsed follicular B-cell non-Hodgkin lymphoma (FL), relapsed small lymphocytic lymphoma (SLL)
Place in therapy: Used for relapsed CLL in combination with standard treatment (rituximab); also for NHL and SLL in patients who have failed two other systemic therapies
Beleodaq® (belinostat) Jul 2014 Oncology IV infusion for refractory peripheral T-Cell lymphoma (PTCL)
Place in therapy: For treatment of relapsed or refractory PTCL
Butrans® (bupenorphine) Transdermal System 7.5mcg/hr Jul 2014 Pain Partial opioid agonist for severe pain
Place in therapy: New low-strength option for Butrans in patients for whom Butrans is indicated
Bunavail (buprenorphine) Jun 2014 Pain naloxone buccal film for treatment of opioid dependence
Note: May be used to treat pain as with similar products Suboxone® and generic versions.
Tedizolid Jun 2014 Anti-infectives oral antibiotic (similar to Zyvox®) (priority review requested)
Ferric citrate coordination complex Jun 2014 Specialty to reduce blood phosphate levels in patient with chronic kidney disease who receive dialysis
BEMA buprenorphine (buccal film) Jun 2014 Pain opioid for severe chronic pain
Note: Concern for abuse potential.
Bunavail™ (buprenorphine/naloxone) Jun 2014 Pain Naloxone buccal film for treatment of opioid dependence
Place in therapy: May be considered if traditional opioid dependence products are ineffective or not tolerated; consider for step therapy
Afrezza® (insulin human) Jun 2014 Diabetes Rapid-acting inhaled insulin for Type 1 or 2 diabetes
Place in therapy: May be considered if patient is unable to tolerate traditional insulin injections
CompleoTRT™ May 2014 Opioid Side Effects testosterone bioadhesive intranasal gel for testosterone replacement
Celebrex® (celecoxib) May 2014 Pain an NSAID
Lunesta® (eszopiclone) May 2014 Hypnotic hypnotic/sleep aid
Celebrex® (celecoxib) 50mg, 100mg, 200mg, 400mg May 2014 Pain NSAID for rheumatoid and osteoarthritis, acute pain
Place in therapy: Expected to be used prior to brand name Celebrex; however, traditional NSAID options should still be tried first
Pennsaid® (diclofenac) 1.5% May 2014 Arthritic Pain Topical NSAID for osteoarthritis pain of the knee
Place in therapy: Expected to be used prior to brand name Pennsaid; however, traditional NSAID options should still be tried first
Exalgo® (hydromorphone HCl extended release) 8mg, 12mg, 16mg May 2014 Pain Opioid analgesic for moderate to severe pain
Place in therapy: Expected that generic should be used prior to brand name Exalgo
Dalvance® (dalbavancin) May 2014 Anti-infectives IV infusion antibiotic for acute bacterial skin and skin structure infections
Place in therapy: Alternative to vancomycin, Zyvox®, and other traditional MRSA treatments; benefit of two-dose regimen, but more costly
Afrezza Apr 2014 Diabetes nasally inhaled ultra-rapid-acting insulin for Type 1 and 2 diabetes
Abiglutide Apr 2014 Diabetes once-weekly injectable for Type 2 diabetes
Pennsaid® 1% (diclofenac) Apr 2014 Pain a topical NSAID solution for osteoarthritis of the knee
Note: Manufacturer has already started marketing a 2% Pennsaid. It is anticipated that the 1% formulation will be discontinued.
Viracept® (nelfinavir) Apr 2014 Specialty oral antiviral for HIV/AIDS
ZykadiaTM (certinib) Apr 2014 Oncology Oral agent for metastatic non-small cell lung cancer (NSCLC)
Place in therapy: Treatment option for NSCLC patients with an ALK mutation who have progressed on or are intolerant to crizotinib
Evzio® (naloxone HCl) injection Apr 2014 Emergency/Antidote Auto-injector for emergency treatment of opioid overdose
Place in therapy: First-of-its-kind antidote for opioid overdose in the ambulatory care setting; approved for use in select states
Tanzeum® (albiglutide) Apr 2014 Diabetes Subcutaneous injection for type 2 diabetes
Place in therapy: May be seen used as monotherapy or add-on therapy for type 2 diabetes; same class as Byetta® and Victoza®
Zohydro ER Mar 2014 Pain hydrocodone bitarate extended-release opioid
Note: Concern for potential abuse
Empagliflozin Mar 2014 Diabetes an oral medication for type 2 diabetes
Note: this will be the third product in a new class of type 2 diabetes medications
Otezla® (apremilast) Mar 2014 Arthritic Pain Oral treatment for psoriatic arthritis
Place in therapy: Not addressed by most recent guidelines (2008); however, expected to compete with current 1st line therapies as the only oral agent approved for psoriatic arthritis
Xartemis® XR (acetaminophen/oxycodone HCl) Mar 2014 Pain Extended-release opioid analgesic combination for acute severe pain
Place in therapy: Expected to compete with other long-acting opioid agents
Northera™ (droxidopa) Feb 2014 Cardiovascular Antihypotensive for orthostatic dizziness, lightheadedness in adults with symptomatic neurogenic orthostatic hypotension
Place in therapy: May be tried as an alternative if midodrine is ineffective
Imbruvica® (ibrutinib) Feb 2014 Oncology Oral agent for chronic lymphocytic leukemia (CLL) and mantle cell leukemia (MCL)
Place in therapy: May be used for treatment of patients with CLL or MCL who have received at least one prior therapy
Tivorbex® (indomethacin)  Feb 2014 Pain A lower-dose NSAID for mild to moderate acute pain
Place in therapy: Should only be considered once other traditional NSAID options have failed, including generic indomethacin; may be considered for step therapy
Hysingla™ ER (hydrocodone bitartrate) extended-release tablets Jan 2014 Pain For the management of severe pain; abuse-deterrent features
Note: Schedule II controlled substance
Abiglutide Jan 2014 Diabetes once-weekly injectable for Type 2 diabetes
Hetlioz® (tasimelteon) Jan 2014 Hypnotic Sleep aid for non-24-hour sleep-wake disorder (Non-24)
Place in therapy:May consider after 1st line therapies such as zolpidem IR or cognitive behavioral therapy (CBT) failure
Epivir-HBV® (lamivudine) 100mg Jan 2014 Antiviral Oral reverse transcriptase inhibitor for chronic hepatitis
Place in therapy:  Guidelines recommend as an option for Hep B treatment based on patient-specific factors; would expect to use generic before brand
Rapamune® (sirolimus) 0.5mg Jan 2014 Transplant Kidney transplant rejection
Place in therapy: Not recommended as initial option for transplant rejection; considered to be a non-preferred alternative to 1st line agents (e.g., tacrolimus) beyond the early post-transplant period
Pennsaid® (diclofenac) 2% Jan 2014 Arthritic Pain Topical NSAID for osteoarthritis pain of the knee
Place in therapy: Should only be considered once other traditional NSAID options have failed, including oral diclofenac tablets; may be considered for step therapy
Farxiga® (dapagliflozin) Jan 2014 Diabetes Oral medication for Type 2 diabetes
Place in therapy: Novel mechanism of action for diabetes medications; may be considered for monotherapy or add-on therapy. The secondary weight-loss benefit may be particularly beneficial in patients who also require weight loss or large insulin doses