News Release Detail
Mylan Announces Tentative FDA Approval for Paroxetine Hydrochloride Extended-Release Tablets
Mylan's ANDA is eligible to receive final approval on June 29, 2007, concurrent with the expiration of the pediatric exclusivity associated with U.S. patent 4,721,723.
Paroxetine Hydrochloride Extended-release Tablets are the generic version of GlaxoSmithKline's Paxil CR®. Paroxetine Hydrochloride Extended-release Tablets had U.S. sales of approximately $307 million for the 12 months ending March 31, 2007, for the same strengths.
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.
For more information about Mylan, please visit www.mylan.com.
SOURCE Mylan Laboratories Inc.
CONTACT: Patrick Fitzgerald or Kris King, for Mylan Laboratories Inc.,
+1-724-514-1800
Web site: http://www.mylan.com