First-Time Generic Approvals: Paxil Suspension, Pamine, Mavik

Yael Waknine

January 12, 2007

January 12, 2007 — The US Food and Drug Administration (FDA) has approved first-time generic formulations for paroxetine HCl 10-mg/5-mL oral suspension in the treatment of certain psychiatric disorders; methscopolamine bromide 2.5- and 5-mg tablets for the adjunctive treatment of peptic ulcer; and trandolapril 1-, 2-, and 4-mg tablets for the management of hypertension and to decrease the risk for cardiac morbidity and mortality in certain patients.


Generic Paroxetine HCl Oral Solution (Paxil) for Certain Psychiatric Disorders

On December 4, the FDA approved a first-time generic formulation for paroxetine HCl 10-mg/5-mL oral suspension (made by Apotex, Inc; brand name Paxil, made by GlaxoSmithKline).

Generic formulations for paroxetine 10-, 20-, 30-, and 40-mg tablets were previously approved by the FDA.

Paroxetine is a selective serotonin reuptake inhibitor (SSRI) and is indicated for the treatment of major depressive, obsessive-compulsive, panic, social anxiety, generalized anxiety, and posttraumatic stress disorders.


Generic Methscopolamine Bromide 2.5- and 5-mg Tablets (Pamine and Pamine Forte) for Peptic Ulcer

On December 28, the FDA approved first-time generic formulations for methscopolamine bromide 2.5- and 5-mg tablets (made by Boca Pharmacal, Inc; brand names Pamine and Pamine Forte, made by Bradley Pharmaceuticals, Inc).

According to a news release, the company's A. Aarons Inc unit commercially launched the products on December 29, 2006.

Methscopolamine is an anticholinergic drug indicated for the adjunctive treatment of peptic ulcer.


Generic Trandolapril 1-, 2, and 4-mg Tablets (Mavik) for Hypertension

On December 12, the FDA approved first-time generic formulations for trandolapril 1-, 2-, and 4-mg tablets (made by Teva Pharmaceuticals USA; brand name Mavik, made by Abbott Laboratories, Inc).

Trandolapril is an angiotensin-converting enzyme (ACE) inhibitor and is indicated for use alone or in combination with other agents such as hydrochlorothiazide for the treatment of hypertension.

Trandolapril also may be used in stable patients with evidence of left ventricular systolic dysfunction or who are symptomatic from congestive heart failure within the first few days of sustaining acute myocardial infarction. Use of trandolapril in white patients has been shown to decrease the risk for death (principally cardiovascular death) and heart failure–related hospitalization.

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