Mylan Gets FDA Approval for Carbidopa and Levodopa Extended-Release Tablets

Mylan Laboratories Inc. (Pittsburgh) has received FDA approval to manufacture and market Carbidopa and Levodopa Extended-Release Tablets in 25 mg/100 mg strength. The product is a generic version of DuPont Pharmaceutical's Sinemet CR Tablets, and is indicated for the treatment of the symptoms of idiopathic Parkinson's disease, postencephalitic parkinsonism, and symptomatic parkinsonism.

The product is being manufactured at Mylan's Morgantown, WV facility and is being shipped immediately.

Mylan had previously received final approval on the 50 mg/200 mg strength of Carbidopa and Levodopa Extended-Release Tablets.

Mylan Laboratories manufactures prescription generic drugs, including antibiotics, anti-inflammatories, beta-blockers, and laxatives, for wholesalers, distributors, and retail drugstore chains.

For more information: Patricia Sunseri, Mylan Laboratories Inc., 1030 Century Bldg., 130 7th St., Pittsburgh, PA 15222. Tel: 412-232-0100. Fax: 412-232-0123.

Edited by Jim Pomager