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New Drug Approvals Archive - February 2018

See also: New Indications and Dosage Forms for February 2018

February 2018

Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) Tablets

Date of Approval: February 7, 2018
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection

Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) is an integrase strand transfer inhibitor and emtricitabine/tenofovir alafenamide (Descovy) combination for the treatment of HIV-1 infection in adults.

Dexycu (dexamethasone) Intraocular Suspension

Date of Approval: February 9, 2018
Company: EyePoint Pharmaceuticals, Inc.
Treatment for: Postoperative Ocular Inflammation

Dexycu (dexamethasone) is a long-acting, injectable corticosteroid formulation administered intraocularly into the posterior chamber of the eye for the treatment of postoperative inflammation associated with cataract surgery.

Symdeko (ivacaftor/tezacaftor and ivacaftor) Tablets

Date of Approval: February 12, 2018
Company: Vertex Pharmaceuticals Incorporated
Treatment for: Cystic Fibrosis

Symdeko (ivacaftor/tezacaftor tablets and ivacaftor tablets) is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator and CFTR corrector combination for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have two copies of the F508del mutation, or who have at least one mutation in the CF gene that is responsive to treatment with Symdeko.

Erleada (apalutamide) Tablets

Date of Approval: February 14, 2018
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Prostate Cancer

Erleada (apalutamide) is an oral androgen receptor inhibitor for the treatment of men with non-metastatic castration-resistant prostate cancer (CRPC).

Osmolex ER (amantadine hydrochloride) Extended-Release Tablets

Date of Approval: February 20, 2018
Company: Osmotica Pharmaceutical US LLC
Treatment for: Parkinson's Disease, Extrapyramidal Reaction

Osmolex ER (amantadine hydrochloride) is a proprietary formulation of immediate release and extended release amantadine for the once-a-day treatment of Parkinson’s disease and drug-induced extrapyramidal reactions.

Apadaz (acetaminophen and benzhydrocodone hydrochloride) Tablets - formerly KP201

Date of Approval: February 23, 2018
Company: KemPharm, Inc.
Treatment for: Pain

Apadaz (acetaminophen and benzhydrocodone hydrochloride) is an immediate release combination of acetaminophen and benzhydrocodone, a prodrug of the opioid agonist hydrocodone, indicated for the short-term management of acute pain.

ZTlido (lidocaine) Patch - formerly Ztilido

Date of Approval: February 28, 2018
Company: Scilex Pharmaceuticals, Inc.
Treatment for: Postherpetic Neuralgia

ZTlido (lidocaine topical system 1.8%) is a transdermal anesthetic formulation for the treatment of pain associated with postherpetic neuralgia.

Symfi Lo (efavirenz, lamivudine and tenofovir disoproxil fumarate) Tablets

Date of Approval: February 5, 2018
Company: Mylan N.V.
Treatment for: HIV Infection

Symfi Lo (efavirenz, lamivudine and tenofovir disoproxil fumarate) is a three-drug combination of a non-nucleoside reverse transcriptase inhibitor (efavirenz), and two nucleo(t)side reverse transcriptase inhibitors (lamivudine and tenofovir disoproxil fumarate) indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

Cimduo (lamivudine and tenofovir disoproxil fumarate) Tablets

Date of Approval: February 28, 2018
Company: Mylan N.V.
Treatment for: HIV Infection

Cimduo (lamivudine and tenofovir disoproxil fumarate) is a combination of two nucleo(t)side reverse transcriptase inhibitors indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

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