Drug Development

Mylan Announces Final FDA Approval for Doxycycline Tablets, 150mg

Published in Medical Letter on the CDC and FDA, July 1st, 2007

Mylan Laboratories Inc. (NYSE:MYL) announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Doxycycline Tablets, 150 mg.

Doxycycline Tablets are the generic version of Par Pharmaceutical's Doxycycline Tablets, 150mg, marketed as Adoxa(R) Tablets by Doak Dermatologics. Doxycycline Tablets had U.S. sales of approximately $34 million for the 12 months ending March 31, 2007, for the 150 mg strength.

In addition to this new product strength, Mylan previously received approval and is marketing the 50 mg, 75 mg and 100 mg strengths of...

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Source: Medical Letter on the CDC and FDA (2007-07-01)

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