First-Time Generic Approvals: Foscavir, Agrylin, Prefest

Yael Waknine

June 10, 2005

June 10, 2005 — The U.S. Food and Drug Administration (FDA) has approved first-time generic formulations of foscarnet sodium 2.4-g/100-mL injection for the treatment of cytomegalovirus retinitis and herpes simplex viral infections; 0.5- and 1-mg [base] anagrelide HCl capsules for the treatment of thrombocythemia; and estradiol 1-mg tablets plus estradiol/norgestimate 1-mg/0.09-mg tablets for the treatment of menopausal symptoms and prevention of postmenopausal osteoporosis.

First-Time Generic Foscarnet Sodium Injection (Foscavir) for CMV, HSV

On May 31, the FDA approved a first-time generic formulation of foscarnet sodium 2.4-g/100-mL injection (made by PharmaForce, Inc.; reference drug, Foscavir, made by AstraZeneca, LP).

Foscarnet sodium injection is indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS and for the treatment of acyclovir-resistant mucocutaneous herpes simplex viral (HSV) infections in immunocompromised patients.

First-Time Generic Anagrelide 0.5- and 1-mg (Agrylin) Capsules for Thrombocythemia

On April 18, the FDA approved first-time generic formulations of 0.5- and 1-mg [base] anagrelide HCl capsules (made by Impax Laboratories, Inc., Ivax Pharmaceuticals, Inc., Roxane Laboratories, Inc., Watson Laboratories, Inc., Barr Laboratories, Inc., Eon Labs, Inc., and Mylan Pharmaceuticals, Inc.; reference drug, Agrylin, made by Shire Inc.).

Anagrelide HCl capsules are indicated for the treatment of thrombocythemia secondary to myeloproliferative disorders to reduce elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombohemorrhagic events.

First-Time Generic Estradiol 1-mg and Estradiol/Norgestimate 1-mg/0.09-mg Tablets (Prefest) for Menopausal Symptoms

On April 29, the FDA approved a first-time generic formulation of estradiol 1-mg tablets plus estradiol/norgestimate 1-mg/0.09-mg tablets (made by Barr Laboratories, Inc.; reference drug, Prefest, made by King Pharmaceuticals, Inc.).

The tablets are indicated for use in women with a uterus for the treatment of moderate to severe symptoms of menopause (vasomotor symptoms, vulvar, and vaginal atrophy) and for the prevention of postmenopausal osteoporosis.

Reviewed by Gary D. Vogin, MD

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