First-Time Generic Approvals: Colestid, Didrex, Percocet

Yael Waknine

May 16, 2006

May 16, 2005 — The US Food and Drug Administration (FDA) has approved first-time generic formulations of cholestipol HCl 5-g packets and scoopfuls for oral suspension as adjunctive therapy to diet in patients with hypercholesterolemia; benzphetamine HCl 50-mg tablets for the short-term management of obesity; and oxycodone HCl plus acetaminophen 10-mg/650-mg tablets for the relief of moderate to moderately severe pain.


Generic Cholestipol HCl Oral Suspension (Colestid) for Hypercholesterolemia

On May 2, the FDA approved first-time generic formulations of cholestipol HCl 5-g packet and scoopful for oral suspension (made by Impax Laboratories, Inc; brand name Colestid, made by Pfizer, Inc).

Cholestipol oral suspension is indicated as an adjunctive therapy to diet for the reduction of elevated serum total and low-density lipoprotein cholesterol in patients with primary hypercholesterolemia who do not respond adequately to diet.


Generic Benzphetamine HCl 50-mg Tablets (Didrex) for Weight Loss

On April 17, the FDA approved a first-time generic formulation for benzphetamine HCl 50-mg tablets (made by Paddock Laboratories, Inc; brand name Didrex, made by Pfizer, Inc).

Benzphetamine tablets are indicated for the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction. According to the FDA, the limited usefulness of agents in this class should be weighed against possible risk inherent in their use.


Generic Oxycodone HCl/Acetaminophen 10-mg/650-mg Tablets (Percocet) for Pain Relief

On April 19, the FDA approved a first-time generic formulation for oxycodone HCl plus acetaminophen 10-mg/650-mg tablets (made by Mikart, Inc; brand name Percocet, made by Endo Pharmaceuticals, Inc).

Oxycodone plus acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.

Reviewed by Gary D. Vogin, MD

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