News Release Detail
August 26, 2005
Mylan Announces Tentative Approval for Ondansetron Hydrochloride Tablets
Mylan Announces Tentative Approval for Ondansetron Hydrochloride Tablets
Mylan Announces Tentative Approval for Ondansetron Hydrochloride TabletsPITTSBURGH, Aug. 26 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc.
(NYSE: MYL) today announced that Mylan Pharmaceuticals Inc. has received
tentative approval from the U.S. Food and Drug Administration (FDA) for its
Abbreviated New Drug Application (ANDA) for Ondansetron Hydrochloride
Tablets, 4 mg, 8 mg, 16 mg, and 24 mg. Ondansetron HCl Tablets are the
generic version of GlaxoSmithKline's Zofran® Tablets, which had annual sales
of approximately $600 million, based on IMS data, for the 12 month period
ended June 30, 2005.
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.
08/26/2005
CONTACT: Patrick Fitzgerald or Kris King, of Mylan Laboratories Inc.,
+1-724-514-1800
Web site: http://www.mylan.com
(MYL)