First-Time Generic Approvals: Climara, Toprol XL, Effexor

Yael Waknine

August 11, 2006

August 11, 2006 — The US Food and Drug Administration (FDA) has approved first-time generic formulations of an estradiol transdermal system for the treatment of menopausal symptoms and hypoestrogenism, and the prevention of postmenopausal osteoporosis; metoprolol succinate extended-release tablets for the treatment of hypertension and angina; and venlafaxine HCl tablets for the treatment of major depressive disorder.


Generic 0.0375- and 0.06-mg/day Estradiol Transdermal System Formulations (Climara) for Menopausal Symptoms, Other Indications

On July 20, the FDA approved first-time 0.0375-mg/day and 0.06-mg/day generic formulations of an estradiol transdermal system (made by Mylan Technologies, Inc; brand name Climara, made by Berlex Laboratories, Inc).

Previously approved generic formulations include 0.025 mg/day, 0.075 mg/day, 0.05 mg/day, and 0.1 mg/day.

Estradiol transdermal systems are indicated for the treatment of moderate to severe vasomotor and vulvovaginal symptoms associated with menopause, and for prevention of postmenopausal osteoporosis. They are also indicated for the treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure.


Generic Metoprolol Succinate 25-mg Extended-Release Tablets (Toprol XL) for Hypertension, Angina

On July 31, the FDA approved a first-time generic formulation of metoprolol succinate 25-mg extended-release tablets (made by Sandoz, Inc; brand name Toprol XL, made by AstraZeneca, LP).

Metoprolol extended-release tablets are indicated for the treatment of hypertension and the long-term treatment of angina pectoris.


Generic Venlafaxine HCl 25-, 37.5-, 50-, 75-, and 100-mg Tablets (Effexor) for Depression

On August 3, the FDA approved first-time generic formulations of venlafaxine HCl 25-, 37.5-, 50-, 75-, and 100-mg tablets (made by Teva Pharmaceuticals USA; brand name Effexor, made by Wyeth Pharmaceuticals, Inc).

Venlafaxine tablets are indicated for the treatment of major depressive disorder.


Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.

processing....