First-Time Generic Approvals: Xanax XR, Dostinex, Percocet

Yael Waknine

February 03, 2006

Feb. 3, 2006 — The US Food and Drug Administration (FDA) has approved first-time generic formulations of alprazolam 0.5-mg extended-release tablets for the treatment of panic disorder, and cabergoline 0.5-mg tablets for the treatment of hyperprolactinemic disorders. First-time doses (ie, no brand equivalent) have also been approved in generic formulations for oxycodone HCl plus acetaminophen 2.5/300-mg, 5/300-mg, 7.5/300-mg, and 10/300-mg tablets for the relief of moderate to moderately severe pain.


Generic Alprazolam Extended-Release Tablets (Xanax XR) for Panic Disorder

On January 27, the FDA approved a first-time generic formulation for alprazolam 0.5-mg extended-release tablets (made by Mylan Pharmaceuticals, Inc; brand name Xanax XR, made by Pfizer, Inc).

Alprazolam extended-release tablets are indicated for the treatment of panic disorder with or without agoraphobia.


Generic Cabergoline Tablets (Dostinex) for Hyperprolactinemic Disorders

On December 29, the FDA approved a first-time generic formulation for cabergoline 0.5-mg tablets (made by Par Pharmaceutical, Inc; brand name Dostinex, made by Pfizer, Inc).

Cabergoline tablets are indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas.


Generic Oxycodone HCl/Acetaminophen Tablets for Pain Relief

On December 30, the FDA approved first-time generic doses of oxycodone HCl plus acetaminophen 2.5/300-mg, 5/300-mg, 7.5/300-mg, and 10/300-mg tablets (made by Mikart, Inc; brand name Percocet, made by Endo Pharmaceuticals, Inc).

Brand-name oxycodone/acetaminophen tablets are marketed in 2.5/325-mg, 5/325-mg, 7.5/325-mg, 10/325-mg, 7.5/500-mg and 10/650-mg doses. All but the 2.5/325-mg combination tablets are available in generic formulations.

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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