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

Get news by email or subscribe to our news feeds.

Xofigo (radium Ra 223 dichloride) Injection

Company: Bayer HealthCare Pharmaceuticals Inc.
Date of Approval: May 15, 2013
Treatment for: Prostate Cancer

Xofigo (radium Ra 223 dichloride) is an alpha particle-emitting radioactive therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer.

Xofigo FDA Approval History

Breo Ellipta (fluticasone and vilanterol) Inhalation Powder

Company: GlaxoSmithKline plc (GSK) and Theravance, Inc.
Date of Approval: May 10, 2013
Treatment for: Chronic Obstructive Pulmonary Disease

Breo Ellipta (fluticasone and vilanterol) is a once-a-day inhaled corticosteroid/long-acting beta2 agonist (LABA) combination indicated for the treatment of patients with chronic obstructive pulmonary disease (COPD).

Breo Ellipta FDA Approval History

Nymalize (nimodipine) Oral Solution

Company: Arbor Pharmaceuticals
Date of Approval: May 10, 2013
Treatment for: Subarachnoid Hemorrhage

Nymalize (nimodipine) is a calcium channel blocker indicated to improve neurological outcome following subarachnoid hemorrhage.

Nymalize FDA Approval History

Liptruzet (atorvastatin and ezetimibe) Tablets

Company: Merck
Date of Approval: May 3, 2013
Treatment for: Heterozygous Familial Hypercholesterolemia

Liptruzet (atorvastatin and ezetimibe) is a statin (HMG-CoA reductase inhibitor) and cholesterol absorption inhibitor combination indicated for the treatment of hyperlipidemia.

Liptruzet FDA Approval History

Procysbi (cysteamine bitartrate) Delayed-Release Capsules - formerly RP103

Company: Raptor Pharmaceutical Corp.
Date of Approval: April 30, 2013
Treatment for: Nephropathic Cystinosis

Procysbi (cysteamine bitartrate) is a cystine depleting agent indicated for the treatment of nephropathic cystinosis.

Procysbi FDA Approval History

Kcentra (prothrombin complex concentrate, human)

Company: CSL Behring
Date of Approval: April 29, 2013
Treatment for: Reversal of Vitamin K Antagonist (VKA) Anticoagulation

Kcentra FDA Approval History

Simbrinza (brimonidine and brinzolamide) Ophthalmic Suspension

Company: Alcon
Date of Approval: April 19, 2013
Treatment for: Glaucoma

Simbrinza (brimonidine and brinzolamide) is a fixed combination of an alpha 2 adrenergic receptor agonist and a carbonic anhydrase inhibitor indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Simbrinza FDA Approval History

Sitavig (acyclovir) Buccal Tablets

Company: BioAlliance Pharma SA
Date of Approval: April 12, 2013
Treatment for: Herpes Simplex Labialis

Sitavig (acyclovir) is a mucoadhesive buccal tablet formulation of the antiviral drug acyclovir indicated for the treatment of recurrent orofacial herpes (cold sores).

Sitavig FDA Approval History

Diclegis (doxylamine and pyridoxine) Delayed-Release Tablets

Company: Duchesnay Inc.
Date of Approval: April 8, 2013
Treatment for: Nausea and Vomiting of Pregnancy

Diclegis (doxylamine and pyridoxine) is an antihistamine and vitamin B6 analog combination indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.

Diclegis FDA Approval History

Prolensa (bromfenac) Ophthalmic Solution

Company: Bausch + Lomb
Date of Approval: April 5, 2013
Treatment for: Postoperative Ocular Inflammation

Prolensa (bromfenac ophthalmic solution) is a topical nonsteroidal anti-inflammatory indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.

Prolensa FDA Approval History

Invokana (canagliflozin) Tablets

Company: Janssen Research & Development, LLC
Date of Approval: March 29, 2013
Treatment for: Diabetes Type 2

Invokana (canagliflozin) is a selective sodium glucose co-transporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.

Invokana FDA Approval History

Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) Tablets

Company: Teva Branded Pharmaceutical Products R&D, Inc.
Date of Approval: March 28, 2013
Treatment for: Contraception

Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) is a 91-day extended regimen oral contraceptive indicated for the prevention of pregnancy.

Quartette FDA Approval History

Karbinal ER (carbinoxamine) Extended-Release Oral Suspension

Company: Tris Pharma, Inc.
Date of Approval: March 28, 2013
Treatment for: Allergic Conjunctivitis, Allergic Reaction, Allergic Rhinitis, Allergic Urticaria

Karbinal ER (carbinoxamine maleate) extended-release oral suspension is an H1 receptor antagonist indicated for the symptomatic treatment of seasonal and perennial allergic rhinitis.

Karbinal ER FDA Approval History

Tecfidera (dimethyl fumarate) Delayed-Release Capsules - formerly BG-12

Company: Biogen Idec
Date of Approval: March 27, 2013
Treatment for: Multiple Sclerosis

Tecfidera (dimethyl fumarate) is an oral Nrf2 pathway activator for the treatment of relapsing forms of multiple sclerosis.

Tecfidera FDA Approval History

TOBI Podhaler (tobramycin) Inhalation Powder

Company: Novartis Pharmaceuticals Corporation
Date of Approval: March 22, 2013
Treatment for: Cystic Fibrosis

TOBI Podhaler (tobramycin inhalation powder) is an antibacterial aminoglycoside indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa.

TOBI Podhaler FDA Approval History

Dotarem (gadoterate meglumine) Injection

Company: Guerbet
Date of Approval: March 20, 2013
Treatment for: Diagnostic

Dotarem (gadoterate meglumine) is a gadolinium-based contrast agent indicated for use in magnetic resonance imaging (MRI).

Dotarem FDA Approval History

Lymphoseek (technetium Tc 99m tilmanocept) Injection

Company: Navidea Biopharmaceuticals
Date of Approval: March 13, 2013
Treatment for: Diagnostic

Lymphoseek (technetium Tc 99m tilmanocept) Injection is a radioactive diagnostic agent indicated for lymphatic mapping with a hand-held gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma.

Lymphoseek FDA Approval History

Osphena (ospemifene) Tablets

Company: Shionogi Inc.
Date of Approval: February 26, 2013
Treatment for: Dyspareunia

Osphena (ospemifene) is an estrogen agonist/antagonist indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause.

Osphena FDA Approval History

Kadcyla (ado-trastuzumab emtansine) Injection

Company: Genentech, Inc.
Date of Approval: February 22, 2013
Treatment for: Breast Cancer

Kadcyla (ado-trastuzumab emtansine) is a HER2-targeted antibody and microtubule inhibitor conjugate indicated for the treatment of patients with HER2-positive, metastatic breast cancer.

Kadcyla FDA Approval History

Vituz (chlorpheniramine and hydrocodone) Oral Solution

Company: Hawthorn Pharmaceuticals, Inc.
Date of Approval: February 20, 2013
Treatment for: Cough, Cold Symptoms

Vituz (chlorpheniramine and hydrocodone) Oral Solution is an antihistamine/antitussive combination indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold.

Vituz FDA Approval History

Help us improve Drugs.com: Take our quick 1 question survey

Close
(web3)