New Drug Approvals Archive - 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.

• FDA Approves Ravicti for the Chronic Management of Some Urea Cycle Disorders

Ravicti (glycerol phenylbutyrate) FDA Approval History

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.

• Warner Chilcott Announces FDA Approval of New Ulcerative Colitis Product Delzicol

Delzicol (mesalamine) FDA Approval History

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.

• FDA Approves Pomalyst for Advanced Multiple Myeloma

Pomalyst (pomalidomide) FDA Approval History

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.

• FDA Approves Kadcyla for Late-Stage Breast Cancer

Kadcyla (ado-trastuzumab emtansine) FDA Approval History

Epiduo (adapalene and benzoyl peroxide)

Patient Population Altered: February 1, 2013

• Epiduo Gel Becomes First Topical Prescription Acne Treatment Available For Children As Young As 9 Years Old

Epiduo (adapalene and benzoyl peroxide) FDA Approval History

Stivarga (regorafenib)

New Indication Approved: February 25, 2013

• FDA Approves Stivarga for Advanced Gastrointestinal Stromal Tumors

Stivarga (regorafenib) FDA Approval History

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.

• FDA Approves Osphena for Postmenopausal Women Experiencing Dyspareunia

Osphena (ospemifene) FDA Approval History

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.

• Pernix Therapeutics Receives FDA Approval for Vituz

Vituz (chlorpheniramine and hydrocodone) FDA Approval History

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

Abilify Maintena (aripiprazole) is an atypical antipsychotic indicated for the treatment of schizophrenia.

• FDA Approves Once-Monthly Abilify Maintena (aripiprazole) for Extended-Release Injectable Suspension for the Treatment of Schizophrenia

Abilify Maintena (aripiprazole) FDA Approval History

Abilify Maintena (aripiprazole)

New Dosage Form Approved: September 29, 2014

• FDA Approves Dual-Chamber Syringe for Abilify Maintena (aripiprazole) for Schizophrenia

Abilify Maintena (aripiprazole) FDA Approval History

Abilify Maintena (aripiprazole)

Labeling Revision Approved: December 5, 2014

• FDA Approves Labeling Update Of Abilify Maintena for Acutely Relapsed Adults With Schizophrenia

Abilify Maintena (aripiprazole) FDA Approval History