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

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Esbriet (pirfenidone) Capsules

Company: InterMune, Inc.
Date of Approval: October 15, 2014
Treatment for: Idiopathic Pulmonary Fibrosis

Esbriet (pirfenidone) is a TGF-beta synthesis inhibitor for the treatment of patients with idiopathic pulmonary fibrosis (IPF).

Esbriet FDA Approval History

Ofev (nintedanib) Capsules

Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Date of Approval: October 15, 2014
Treatment for: Idiopathic Pulmonary Fibrosis

Ofev (nintedanib) is a small molecule tyrosine kinase inhibitor (TKI) for the treatment of idiopathic pulmonary fibrosis.

Ofev FDA Approval History

Harvoni (ledipasvir and sofosbuvir)

Company: Gilead Sciences, Inc.
Date of Approval: October 10, 2014
Treatment for: Chronic Hepatitis C

Harvoni (ledipasvir and sofosbuvir) is a once-daily NS5A inhibitor and nucleotide analog polymerase inhibitor fixed-dose combination for the treatment of chronic hepatitis C genotype 1 infection.

Harvoni FDA Approval History

Akynzeo (netupitant and palonosetron) Capsules

Company: Helsinn Group and Eisai Inc.
Date of Approval: October 10, 2014
Treatment for: Nausea/Vomiting -- Chemotherapy Induced

Akynzeo (netupitant and palonosetron) is an oral NK1 receptor antagonist and 5-HT3 receptor antagonist fixed-dose combination indicated for the prevention of chemotherapy-induced nausea and vomiting (CINV).

Akynzeo FDA Approval History

Lumason (sulfur hexafluoride lipid microsphere)

Date of Approval: October 10, 2014
Treatment for: Diagnostic

Lumason FDA Approval History

Vitekta (elvitegravir) Tablets

Company: Gilead Sciences, Inc.
Date of Approval: September 24, 2014
Treatment for: HIV Infection

Vitekta (elvitegravir) is an integrase inhibitor for the combination treatment of HIV-1 infection in treatment-experienced adults.

Vitekta FDA Approval History

Tybost (cobicistat) Tablets

Company: Gilead Sciences, Inc.
Date of Approval: September 24, 2014
Treatment for: HIV Infection

Tybost (cobicistat) is a potent mechanism-based inhibitor of cytochrome P450 3A (CYP3A) which acts as a pharmacoenhancing or "boosting" agent for antiviral drugs used in the treatment of HIV infection.

Tybost FDA Approval History

Trulicity (dulaglutide) Injection

Company: Eli Lilly and Company
Date of Approval: September 18, 2014
Treatment for: Diabetes Type 2

Trulicity (dulaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist for the treatment of type 2 diabetes.

Trulicity FDA Approval History

Movantik (naloxegol) Tablets

Company: AstraZeneca Pharmaceuticals LP
Date of Approval: September 16, 2014
Treatment for: Opioid-Induced Constipation

Movantik (naloxegol) is a peripherally-acting mu-opioid receptor antagonist indicated for the treatment of opioid-induced constipation.

Movantik FDA Approval History

Contrave (bupropion and naltrexone) Tablets

Company: Orexigen Therapeutics, Inc.
Date of Approval: September 10, 2014
Treatment for: Obesity

Contrave (bupropion/naltrexone) is an aminoketone antidepressant and opioid antagonist combination indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management.

Contrave FDA Approval History

ferric citrateTablets - formerly Zerenex

Company: Keryx Biopharmaceuticals, Inc.
Date of Approval: September 5, 2014
Treatment for: Hyperphosphatemia of Renal Failure

Ferric Citrate is a phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.

ferric citrate FDA Approval History

Keytruda (pembrolizumab) for Injection

Company: Merck & Co., Inc.
Date of Approval: September 4, 2014
Treatment for: Melanoma - Metastatic

Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of metastatic melanoma.

Keytruda FDA Approval History

Kabiven (amino acids, electrolytes, dextrose and lipid) Injectable Emulsion

Company: Fresenius Kabi USA
Date of Approval: August 25, 2014
Treatment for: Parenteral Nutrition

Kabiven (amino acids, electrolytes, dextrose and lipid injectable emulsion) is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition.

Kabiven FDA Approval History

Triumeq (abacavir, dolutegravir and lamivudine) Tablets

Company: ViiV Healthcare
Date of Approval: August 22, 2014
Treatment for: HIV Infection

Triumeq (abacavir, dolutegravir and lamivudine) is a fixed-dose combination containing the INSTI dolutegravir and the NRTIs abacavir and lamivudine for the treatment of HIV-1 infection.

Triumeq FDA Approval History

Arnuity Ellipta (fluticasone furoate) Inhalation Powder

Company: GlaxoSmithKline plc
Date of Approval: August 20, 2014
Treatment for: Asthma, Asthma -- Maintenance

Arnuity Ellipta (fluticasone furoate inhalation powder) is a once-daily inhaled corticosteroid for the maintenance treatment of asthma.

Arnuity Ellipta FDA Approval History

Cerdelga (eliglustat) Capsules

Company: Genzyme Corporation
Date of Approval: August 19, 2014
Treatment for: Gaucher Disease

Cerdelga (eliglustat) is a glucosylceramide synthase inhibitor indicated for the long- term treatment of adult patients with Gaucher disease type 1.

Cerdelga FDA Approval History

Plegridy (peginterferon beta-1a) Injection

Company: Biogen Idec
Date of Approval: August 15, 2014
Treatment for: Multiple Sclerosis

Plegridy (peginterferon beta-1a) is a pegylated interferon beta indicated for the treatment of patients with relapsing forms of multiple sclerosis.

Plegridy FDA Approval History

Belsomra (suvorexant) Tablets

Company: Merck, Sharpe & Dohme Corp.
Date of Approval: August 13, 2014
Treatment for: Insomnia

Belsomra (suvorexant) is an orexin receptor antagonist for use in patients with difficulty falling or staying asleep (insomnia).

Belsomra FDA Approval History

Invokamet (canagliflozin and metformin) Tablets

Company: Janssen Research & Development, LLC
Date of Approval: August 8, 2014
Treatment for: Diabetes Type 2

Invokamet (canagliflozin/metformin) is a selective sodium glucose co-transporter 2 (SGLT2) inhibitor and biguanide combination for the treatment of type 2 diabetes.

Invokamet FDA Approval History
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