First-Time Generic Approvals: Flexeril, Plavix, and AndroGel

Yael Waknine

February 21, 2006

Feb. 21, 2006 -- The US Food and Drug Administration (FDA) has approved first-time generic formulations of cyclobenzaprine HCl 5-mg tablets for adjunctive use in the short-term treatment of muscle spasms; clopidogrel bisulfate 75-mg tablets to reduce the risk for atherothrombotic effects in high-risk patients; and testosterone 1% gel for hormone replacement therapy in men.


Generic Cyclobenzaprine HCl 5-mg Tablets (Flexeril) for Short-term Treatment of Muscle Spasms

On February 3, the FDA approved a first-time generic formulation of cyclobenzaprine HCl 5-mg tablets (made by Mylan Pharmaceuticals Inc, Watson Laboratories Inc, Sandoz Inc, and Amide Pharmaceutical Inc; brand name Flexeril, made by McNeil Consumer and Specialty Pharmaceuticals). A generic 10-mg tablet formulation of the product was previously approved.

Cyclobenzaprine is indicated as an adjunct to rest and physical therapy for the relief of muscle spasm associated with acute, painful musculoskeletal conditions. Because adequate evidence of prolonged effectiveness is not available and acute conditions rarely warrant long-term therapy, cyclobenzaprine should not be used for longer than 2 or 3 weeks.


Generic Clopidogrel Bisulfate 75-mg Tablets (Plavix) to Reduce Risk for Atherothrombotic Events

On January 20, the FDA approved a first-time generic formulation of clopidogrel bisulfate 75-mg tablets (made by Apotex Corporation; brand name Plavix, made by Sanofi-Aventis Inc).

Clopidogrel tablets are indicated to reduce the risk for atherothrombotic events in patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease. In clinical studies, clopidogrel decreased the rate of a combined end point of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death.

It is also approved for this indication in patients with acute coronary syndrome (unstable angina/non-Q-wave MI), including those who are to be managed medically and those receiving percutaneous coronary intervention (with or without stent) or coronary artery bypass graft surgery. In clinical studies, clopidogrel decreased the rate of a combined end point of cardiovascular death, MI, stroke, or refractory ischemia in this population.


Generic Testosterone 1% Gel (AndroGel) for Hormone Replacement Therapy in Men

On January 27, the FDA approved a first-time generic formulation of testosterone gel, 1% (made by Watson Laboratories Inc; brand name AndroGel, made by Solvay Pharmaceuticals, Inc).

Testosterone gel is indicated for hormone replacement therapy in men with a deficiency or absence of endogenous testosterone related to congenital or acquired primary and hypogonadotropic hypogonadism. It has not been clinically evaluated in men younger than 18 years.

Reviewed by Gary D. Vogin, MD

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