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Tuesday 16 May 2006
First-Time Generic Approvals: Colestid, Didrex, Percocet
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.
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.