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New Drug Approvals

The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.

See also: Generic Approvals, Approval Process, New Indications and Dosage forms

Crysvita (burosumab-twza) Injection

Company: Ultragenyx Pharmaceutical Inc.
Date of Approval: April 17, 2018
Treatment for: X-Linked Hypophosphatemia

Crysvita (burosumab-twza) is a fibroblast growth factor 23 (FGF23) blocking antibody for the treatment of x-linked hypophosphatemia (XLH).

Crysvita FDA Approval History

Tavalisse (fostamatinib) Tablets

Company: Rigel Pharmaceuticals, Inc.
Date of Approval: April 17, 2018
Treatment for: Idiopathic (Immune) Thrombocytopenic Purpura

Tavalisse (fostamatinib) is an oral spleen tyrosine kinase (SYK) inhibitor for the treatment of patients with chronic immune thrombocytopenia (ITP).

Tavalisse FDA Approval History

Symfi (efavirenz, lamivudine and tenofovir disoproxil fumarate) Tablets

Company: Mylan Pharmaceuticals Inc.
Date of Approval: March 22, 2018
Treatment for: HIV Infection

Symfi (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.

Symfi FDA Approval History

Ilumya (tildrakizumab-asmn) Injection

Company: Sun Pharmaceutical Industries Inc.
Date of Approval: March 20, 2018
Treatment for: Plaque Psoriasis

Ilumya (tildrakizumab-asmn) is a humanized, anti-IL-23p19 monoclonal antibody for the treatment of moderate-to-severe plaque psoriasis.

Ilumya FDA Approval History

Trogarzo (ibalizumab-uiyk) Injection

Company: TaiMed Biologics USA Corp.
Date of Approval: March 6, 2018
Treatment for: HIV Infection

Trogarzo (ibalizumab-uiyk) is a CD4-directed post-attachment HIV-1 inhibitor for the treatment of multidrug resistant human immunodeficiency virus-1 (HIV-1) infection in heavily treatment-experienced adults.

Trogarzo FDA Approval History

Cimduo (lamivudine and tenofovir disoproxil fumarate) Tablets

Company: Mylan Pharmaceuticals Inc.
Date of Approval: February 28, 2018
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.

Cimduo FDA Approval History

ZTlido (lidocaine) Patch - formerly Ztilido

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

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

ZTlido FDA Approval History

Apadaz (acetaminophen and benzhydrocodone hydrochloride) Tablets - formerly KP201

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

Apadaz FDA Approval History

Osmolex ER (amantadine hydrochloride) Extended-Release Tablets

Company: Osmotica Pharmaceutical US LLC
Date of Approval: February 20, 2018
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.

Osmolex ER FDA Approval History

Erleada (apalutamide) Tablets

Company: Janssen Pharmaceuticals, Inc.
Date of Approval: February 14, 2018
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).

Erleada FDA Approval History

Symdeko (ivacaftor/tezacaftor and ivacaftor) Tablets

Company: Vertex Pharmaceuticals Incorporated
Date of Approval: February 12, 2018
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.

Symdeko FDA Approval History

Dexycu (dexamethasone) Intraocular Suspension

Company: Icon Bioscience Inc.
Date of Approval: February 9, 2018
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.

Dexycu FDA Approval History

Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) Tablets

Company: Gilead Sciences, Inc.
Date of Approval: February 7, 2018
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.

Biktarvy FDA Approval History

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

Company: Mylan Pharmaceuticals Inc.
Date of Approval: February 5, 2018
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.

Symfi Lo FDA Approval History

Firvanq (vancomycin hydrochloride) for Oral Solution

Company: CutisPharma
Date of Approval: January 26, 2018
Treatment for: Clostridium Difficile Associated Diarrhea; Enterocolitis

Firvanq (vancomycin hydrochloride) is an oral solution formulation of an approved tricyclic glycopeptide antibiotic for the treatment of Clostridium difficile associated diarrhea and Staphylococcus aureus enterocolitis.

Firvanq FDA Approval History

Lutathera (lutetium Lu 177 dotatate) Injection

Company: Advanced Accelerator Applications S.A.
Date of Approval: January 26, 2018
Treatment for: Gastroenteropancreatic Neuroendocrine Tumors

Lutathera (lutetium Lu 177 dotatate) is a Lu-177-labeled somatostatin analogue indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.

Lutathera FDA Approval History

Balcoltra (ethinyl estradiol/levonorgestrel and ferrous bisglycinate) Tablets

Company: Avion Pharmaceuticals, LLC
Date of Approval: January 9, 2018
Treatment for: Prevention of Pregnancy

Balcoltra (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets) is a progestin/estrogen combination oral contraceptive (COC) indicated for use by females of reproductive potential to prevent pregnancy.

Balcoltra FDA Approval History

Lumify (brimonidine tartrate) Ophthalmic Solution

Company: Bausch & Lomb Inc.
Date of Approval: December 22, 2017
Treatment for: Ocular Redness

Lumify (brimonidine tartrate) is an over-the-counter (OTC) formulation of the alpha-adrenergic agonist brimonidine indicated for use in the treatment of ocular redness.

Lumify FDA Approval History

Giapreza (angiotensin II) Injection - formerly LJPC-501

Company: La Jolla Pharmaceutical Company
Date of Approval: December 21, 2017
Treatment for: Hypotension, Shock

Giapreza (angiotensin II) is a synthetic human angiotensin II vasoconstrictor indicated for the treatment of hypotension in adults with septic or other distributive shock.

Giapreza FDA Approval History
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FDA Drug Approvals Archive