News Release Detail
November 29, 2005
Mylan Announces Final FDA Approval for Glimepiride Tablets
Mylan Announces Final FDA Approval for Glimepiride Tablets
Mylan Announces Final FDA Approval for Glimepiride TabletsPITTSBURGH, Nov. 29 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc.
(NYSE: MYL) today 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 Glimepiride Tablets, 1 mg, 2 mg, and 4 mg.
Glimepiride Tablets are the AB-rated generic equivalent of Aventis
Pharmaceuticals' Amaryl® Tablets, which had U.S. sales of approximately $348
million for the 12-month period ending June 30, 2005, according to IMS Health.
Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories, Inc., that develop, license, manufacture, market and distribute an extensive line of generic and proprietary products.
For more information about Mylan, visit www.mylan.com.
SOURCE Mylan Laboratories Inc.
11/29/2005
CONTACT: Media, Patrick Fitzgerald, or Investors, Kris King, both of
Mylan Laboratories Inc., +1-724-514-1800
Web site: http://www.mylan.com
(MYL)