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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Zerbaxa (ceftolozane and tazobactam)

Company: Cubist Pharmaceuticals, Inc.
Date of Approval: December 19, 2014
Treatment for: Intraabdominal Infection, Urinary Tract Infection

Zerbaxa (ceftolozane and tazobactam) is a cephalosporin and beta-lactamase inhibitor combination for the treatment of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).

Zerbaxa FDA Approval History

Lynparza (olaparib) Capsules

Company: AstraZeneca
Date of Approval: December 19, 2014
Treatment for: Ovarian Cancer

Lynparza (olaparib) is a first-in-class oral poly ADP ribose polymerase (PARP) inhibitor for the treatment of advanced ovarian cancer.

Lynparza FDA Approval History

Viekira Pak (ombitasvir/paritaprevir/ritonavir with dasabuvir) Tablets

Company: AbbVie Inc.
Date of Approval: December 19, 2014
Treatment for: Chronic Hepatitis C

Viekira Pak (ombitasvir/paritaprevir/ritonavir with dasabuvir) is an NS5A inhibitor, NS3/4A protease inhibitor and CYP3A inhibitor combination co-packaged with a non-nucleoside NS5B palm polymerase inhibitor for the treatment of patients with genotype 1 chronic hepatitis C virus (HCV) infection.

Viekira Pak FDA Approval History

Xtoro (finafloxacin) Otic Suspension

Company: Alcon Laboratories, Inc.
Date of Approval: December 17, 2014
Treatment for: Otitis Externa

Xtoro FDA Approval History

Signifor LAR (pasireotide) for Injectable Suspension

Company: Novartis
Date of Approval: December 15, 2014
Treatment for: Acromegaly

Signifor LAR (pasireotide) is a long acting a somatostatin analog formulation for the treatment of patients with acromegaly.

Signifor LAR FDA Approval History

Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) Injection

Company: Merck & Co., Inc.
Date of Approval: December 10, 2014
Treatment for: Human Papillomavirus Prophylaxis

Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) is a 9-valent HPV vaccine for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58.

Gardasil 9 FDA Approval History

Blincyto (blinatumomab) Injection

Company: Amgen Inc.
Date of Approval: December 3, 2014
Treatment for: Acute Lymphoblastic Leukemia

Blinatumomab is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Blincyto FDA Approval History

Kitabis Pak (tobramycin) Inhalation Solution

Company: PulmoFlow, Inc.
Date of Approval: December 2, 2014
Treatment for: Cystic Fibrosis

Kitabis Pak (tobramycin) is an aminoglycoside inhalation solution co-packaged with a PARI LC PLUSĀ® Reusable Nebulizer for the management of cystic fibrosis.

Kitabis Pak FDA Approval History

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) Injection

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
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