New Drug Approvals Archive - December 2011

Anturol (oxybutynin) Gel

Date of Approval: December 7, 2011
Company: Antares Pharma, Inc.
Treatment for: Overactive Bladder

Anturol (oxybutynin) is an anticholinergic transdermal gel formulation indicated for the management of overactive bladder.

• Anturol Approved by FDA for the Treatment of Overactive Bladder

Anturol (oxybutynin) FDA Approval History

Opana (oxymorphone)

New Formulation Approved: December 9, 2011

• Endo Announces FDA Approval of a New Formulation of Opana ER Designed to be Crush-Resistant

Opana (oxymorphone) FDA Approval History

Edarbyclor (azilsartan medoxomil and chlorthalidone) Tablets

Date of Approval: December 20, 2011
Company: Takeda Pharmaceutical Company Limited
Treatment for: Hypertension

Edarbyclor (azilsartan medoxomil and chlorthalidone) is a fixed-dose combination of an angiotensin II receptor blocker (ARB) and a diuretic, indicated for the treatment of hypertension.

• FDA Approves Edarbyclor (azilsartan medoxomil and chlorthalidone) for the Treatment of Hypertension

Edarbyclor (azilsartan medoxomil and chlorthalidone) FDA Approval History

Isentress (raltegravir)

Patient Population Altered: December 21, 2011

• FDA Expands Use of HIV Drug Isentress to Children and Adolescents

Isentress (raltegravir) FDA Approval History