First-Time Generic Approvals: Periostat, TriCor, Foscavir

Yael Waknine

June 21, 2005

June 21, 2005 — The U.S. Food and Drug Administration (FDA) has approved first-time generic formulations of doxycycline hyclate 20-mg tablets USP for adjunctive use in the treatment of adult periodontitis; fenofibrate 54- and 160-mg tablets for use as an adjunct to diet in the treatment of lipid disorders in adults; and foscarnet sodium 24-mg/mL injection in 250- and 500-mL bottles for the treatment of cytomegalovirus retinitis and mucocutaneous herpes simplex viral infections.

Generic Doxycycline Hyclate 20-mg Tablets (Periostat) for Adult Periodontitis

On May 13, the FDA approved a first-time generic formulation of doxycycline hyclate 20-mg tablets USP (made by Mutual Pharmaceutical Company, Inc., Ivax Pharmaceuticals, Inc., and West-Ward Pharmaceutical Corp.; brand name Periostat, made by Collagenex Pharmaceuticals, Inc.).

Doxycycline hyclate tablets are indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocked depth in patients with adult periodontitis.

Generic Fenofibrate 54- and 160-mg Tablets (TriCor) for Lipid Disorders

On May 13, the FDA approved first-time generic formulations of fenofibrate 54- and 160-mg tablets (made by Teva Pharmaceuticals USA; brand name TriCor, made by Abbott Laboratories).

The fenofibrate tablets must be taken with food for optimal absorption and are indicated for use as an adjunct to diet for the treatment of primary hypercholesterolemia, mixed dyslipidemia, and hypertriglyceridemia in adults.

Generic Foscarnet Sodium 24-mg/mL Injection (Foscavir) in 250- and 500-mL Bottles for CMV Retinitis and HSV

On May 31, the FDA approved a first-time generic formulation of foscarnet sodium 24-mg/mL injection in 250- and 500-mL bottles (made by PharmaForce, Inc.; brand name Foscavir, made by AstraZeneca).

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

Reviewed by Gary D. Vogin, MD

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