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New Drug Approvals Archive - February 2013

See also: New Indications and Dosage Forms for February 2013

February 2013

Ravicti (glycerol phenylbutyrate) Oral Liquid

Date of Approval: February 1, 2013
Company: Hyperion Therapeutics
Treatment for: Urea Cycle Disorders

Ravicti (glycerol phenylbutyrate) is a nitrogen-binding agent for the chronic management of patients with urea cycle disorders.

Delzicol (mesalamine) Delayed-Release Capsules

Date of Approval: February 1, 2013
Company: Allergan, Inc.
Treatment for: Ulcerative Colitis

Delzicol (mesalamine) is an aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis and for the maintenance of remission of ulcerative colitis.

Pomalyst (pomalidomide) Capsules

Date of Approval: February 8, 2013
Company: Bristol Myers Squibb
Treatment for: Multiple Myeloma

Pomalyst (pomalidomide) is a thalidomide analogue indicated for the treatment of patients with multiple myeloma and AIDS-related and HIV-negative Kaposi sarcoma.

Kadcyla (ado-trastuzumab emtansine) Injection

Date of Approval: February 22, 2013
Company: Genentech, Inc.
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.

Osphena (ospemifene) Tablets

Date of Approval: February 26, 2013
Company: Duchesnay Inc.
Treatment for: Dyspareunia, Atrophic Vaginitis

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

Vituz (chlorpheniramine and hydrocodone) Oral Solution

Date of Approval: February 20, 2013
Company: Hawthorn Pharmaceuticals, Inc.
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.

Abilify Maintena (aripiprazole) for Extended-Release Injectable Suspension

Date of Approval: February 28, 2013
Company: Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S
Treatment for: Schizophrenia, Bipolar Disorder

Abilify Maintena (aripiprazole) is an atypical antipsychotic indicated for the treatment of schizophrenia, and maintenance monotherapy treatment of bipolar I disorder.

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