Mylan Laboratories Inc. has received final approval from the US FDA for its supplemental ANDA for Fluoxetine capsules USP, 40 mg. Fluoxetine capsules are the generic version of Eli Lilly and company's Prozac capsules.
Fluoxetine capsules had US 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 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 Ltd, India. Mylan develops, licenses, manufactures, markets and distributes an extensive line of generic and proprietary products.