FDA Approves Fluoxetine Capsules USP
Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration for its supplemental Abbreviated New Drug Application for Fluoxetine Capsules USP, 40 mg.
Fluoxetine Capsules are the generic version of Eli Lilly and Company's Prozac Capsules. Fluoxetine Capsules had U.S. sales of approximately $118 million for the 12 months ending March 31, 2007, for the 40 mg strength.
This product will be shipped immediately.
Mylan previously received approval and is currently marketing the 10 mg and 20 mg strength of fluoxetine capsules.
Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories Inc., and a controlling interest in Matrix Laboratories Limited, India. Mylan develops, licenses, manufactures, markets and distributes an extensive line of generic and proprietary products.