Mylan's Matrix Receives Final FDA Approval for the Generic Version of the Antiretroviral Zerit(R) Capsules
30 Dezembro 2008 - 11:00AM
PR Newswire (US)
PITTSBURGH, Dec. 30 /PRNewswire-FirstCall/ -- Mylan Inc.
(NASDAQ:MYL) today announced that Matrix Laboratories Limited, its
India-based subsidiary in which it holds a 71.5% controlling
interest, received final approval from the U.S. Food and Drug
Administration (FDA) on December 29, for its Abbreviated New Drug
Application (ANDA) for Stavudine Capsules USP, 15 mg, 20 mg, 30 mg
and 40 mg. Stavudine Capsules, indicated for the treatment of HIV-1
infection in combination with other antiretroviral agents, are the
generic version of Bristol-Myers Squibb's Zerit(R) Capsules. This
product had annual U.S. sales of approximately $54 million for the
12 months ending Sept. 30, 2008, for the noted strengths, according
to IMS Health. The product was shipped immediately under the Mylan
Pharmaceutical Inc. label. Mylan Inc., which provides products to
customers in more than 140 countries and territories, ranks among
the leading diversified generic and specialty pharmaceutical
companies in the world. The company maintains one of the industry's
broadest - and highest quality - product portfolios, supported by a
robust product pipeline; owns a controlling interest in the world's
third largest active pharmaceutical ingredient manufacturer; and
operates a specialty business focused on respiratory and allergy
therapies. For more information, please visit
http://www.mylan.com/. DATASOURCE: Mylan Inc. CONTACT: Michael
Laffin (Media), +1-724-514-1968, or Dan Crookshank (Investors),
+1-724-514-1813, both of Mylan Inc. Web Site: http://www.mylan.com/
Copyright