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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Onexton (benzoyl peroxide and clindamycin phosphate) Gel

Company: Valeant Pharmaceuticals International, Inc.
Date of Approval: November 25, 2014
Treatment for: Acne

Onexton (benzoyl peroxide and clindamycin phosphate) is an antimicrobial and lincosamide antibacterial combination for the once-daily topical treatment of acne vulgaris.

Onexton FDA Approval History

Hysingla ER (hydrocodone bitartrate) Extended-Release Tablets

Company: Purdue Pharma L.P.
Date of Approval: November 20, 2014
Treatment for: Chronic Pain

Hysingla ER (hydrocodone) is a single-entity (without acetaminophen) extended-release opioid analgesic for around-the-clock management of moderate to severe chronic pain.

Hysingla ER FDA Approval History

Lemtrada (alemtuzumab)

Company: Genzyme
Date of Approval: November 14, 2014
Treatment for: Multiple Sclerosis

Lemtrada (alemtuzumab) is a CD52-directed cytolytic monoclonal antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS).

Lemtrada FDA Approval History

Xigduo XR (dapagliflozin and metformin hydrochloride) Extended-Release Tablets

Company: AstraZeneca
Date of Approval: October 30, 2014
Treatment for: Diabetes Type 2

Xigduo XR (dapagliflozin and metformin hydrochloride) is a once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor and biguanide combination for the treatment of type 2 diabetes.

Xigduo XR FDA Approval History

Trumenba (meningococcal group B vaccine)

Company: Pfizer Inc.
Date of Approval: October 29, 2014
Treatment for: Meningococcal Meningitis Prophylaxis

Trumenba (meningococcal group B vaccine) is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in adolescents and young adults.

Trumenba FDA Approval History

Obizur (antihemophilic factor (recombinant))

Company: Baxter International Inc.
Date of Approval: October 23, 2014
Treatment for: Hemophilia A

Obizur (antihemophilic factor (recombinant)) is an antihemophilic factor indicated for the treatment of bleeding episodes in adults with acquired hemophilia A.

Obizur FDA Approval History

Sotylize (sotalol hydrochloride) Oral Solution

Company: Arbor Pharmaceuticals
Date of Approval: October 22, 2014
Treatment for: Ventricular Arrhythmia, Atrial Fibrillation, Atrial Flutter

Sotylize (sotalol hydrochloride) is an antiarrhythmic indicated for the treatment of ventricular arrhythmias and the maintenance of normal sinus rhythm in patients with history of highly symptomatic atrial fibrillation/flutter.

Sotylize FDA Approval History

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) Tablets

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) Injectable Suspension

Company: Bracco Diagnostics Inc.
Date of Approval: October 10, 2014
Treatment for: Diagnostic

Lumason (sulfur hexafluoride lipid microsphere) is a contrast agent used for ultrasound imaging.

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 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

Auryxia (ferric citrate) Tablets

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.

Auryxia 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
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