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New Drug Approvals Archive

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February 2013

February 1

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.

Ravicti (glycerol phenylbutyrate) FDA Approval History

February 1

Delzicol (mesalamine) Delayed-Release Capsules

Date of Approval: February 1, 2013
Company: Warner Chilcott (US), LLC
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.

Delzicol (mesalamine) FDA Approval History

February 8

Pomalyst (pomalidomide) Capsules

Date of Approval: February 8, 2013
Company: Celgene Corporation
Treatment for: Multiple Myeloma

Pomalyst (pomalidomide) is a thalidomide analogue indicated for the treatment of patients with multiple myeloma.

Pomalyst (pomalidomide) FDA Approval History

February 22

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.

Kadcyla (ado-trastuzumab emtansine) FDA Approval History

February 25

Epiduo (adapalene and benzoyl peroxide)

Patient Population Altered: February 1, 2013

Epiduo (adapalene and benzoyl peroxide) FDA Approval History

February 25

Stivarga (regorafenib)

New Indication Approved: February 25, 2013

Stivarga (regorafenib) FDA Approval History

February 26

Osphena (ospemifene) Tablets

Date of Approval: February 26, 2013
Company: Shionogi Inc.
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 (ospemifene) FDA Approval History

February 20

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.

Vituz (chlorpheniramine and hydrocodone) FDA Approval History

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