First-Time Generic Approvals: Glucotrol XL, Retrovir, Salagen

Yael Waknine

April 07, 2006

April 7, 2006 -- The US Food and Drug Administration (FDA) has approved first-time generic formulations of glipizide 2.5-mg extended-release tablets for the management of type 2 diabetes; zidovudine 100-mg capsules for use with other antiretroviral agents in the treatment of HIV infection; and pilocarpine HCl 7.5-mg tablets for the treatment of dry mouth due to head/neck radiation therapy and Sjögren's syndrome.


Generic Glipizide 2.5-mg Tablets (Glucotrol XL) for Type 2 Diabetes

On March 27, the FDA approved a first-time generic formulation of glipizide 2.5-mg extended-release tablets (made by Watson Laboratories Inc; brand name Glucotrol XL, made by Pfizer, Inc).

Glipizide extended-release tablets are indicated as an adjunct to diet for the control of hyperglycemia and its associated symptomatology in patients with type 2 diabetes. The tablets were previously approved in generic 5- and 10-mg strengths.


Generic Zidovudine 100-mg Capsules (Retrovir) for Combination HIV Treatment

On March 27, the FDA approved a first-time generic formulation for zidovudine 100-mg capsules (made by Aurobindo Pharma Ltd; brand name Retrovir, made by GlaxoSmithKline). The product was reviewed under the President's Emergency Plan for AIDS Relief.

Zidovudine is indicated for use in combination with other antiretroviral agents for the treatment of HIV infection. Generic formulations for the 300-mg tablets and 50-mg/5-mL syrup were previously approved by the FDA.


Generic Pilocarpine 7.5-mg Tablets (Salagen) for the Treatment of Dry Mouth

On April 5, the FDA approved a first-time generic formulation of pilocarpine HCl 7.5-mg tablets (made by IMPAX Laboratories, Inc; brand name Salagen made by MGI Pharma, Inc).

Pilocarpine tablets are indicated for the treatment of dry mouth resulting from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and for the treatment of symptoms of dry mouth in patients with Sjögren's syndrome.

The 5-mg strength of generic pilocarpine was previously approved by the FDA.

Reviewed by Gary D. Vogin, MD

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