News Release Detail
February 6, 2006
Mylan Announces FDA Approval for Cyclobenzaprine Hydrochloride Tablets USP, 5 mg
Mylan Announces FDA Approval for Cyclobenzaprine Hydrochloride Tablets USP, 5 mg
Mylan Announces FDA Approval for Cyclobenzaprine Hydrochloride Tablets USP, 5 mgPITTSBURGH, Feb. 6 /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 supplemental
Abbreviated New Drug Application (ANDA) for Cyclobenzaprine Hydrochloride
Tablets USP, 5 mg. Cyclobenzaprine Tablets are the AB-rated generic
equivalent of McNeil's Flexeril® Tablets. U.S. sales for the 5 mg strength
of Flexeril® were approximately $93 million for the 12-month period ending
June 30, 2005, according to IMS Health.
This product will begin shipping immediately.
Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories Inc. Mylan develops, licenses, manufactures, markets and distributes an extensive line of generic and proprietary products.
For more information about Mylan, visit http://www.mylan.com.
SOURCE Mylan Laboratories Inc. 02/06/2006 CONTACT: Patrick Fitzgerald, or Kris King, both of Mylan Laboratories Inc., +1-724-514-1800 Web site: http://www.mylan.com