PITTSBURGH, Sept. 12 (UPI) -- Mylan said Tuesday the U.S. Food and Drug Administration approved its generic formulation of Ortho-McNeil's migraine medication Topamax.
Mylan's drug is the first generic version of Topamax and is therefore entitled to 180 days of market exclusivity, which the company said will begin when the product is launched or after a court decision.
Topamax has annual U.S. sales of approximately $1.37 billion.
The FDA approval covers 25 mg, 100 mg and 200 mg tablets of Mylan's topiramate. The FDA gave tentative approval for the 50 mg topiramate tablet.
Serious side effects associated with Topamax include metabolic acidosis, hyperventilation and fatigue. Other serious risks consist of glaucoma, kidney stones and difficulty concentrating.
