Mylan Receives Final FDA Approvals for Generic Versions of Lamictal(R) Tablets and Lamictal(R) CDPITTSBURGH,
Jan. 28 /PRNewswire-FirstCall/ --
Mylan Inc. (Nasdaq: MYL)
today announced that its subsidiaries
Mylan Pharmaceuticals Inc. and Genpharm
ULC received final approvals from the
U.S. Food and Drug Administration (FDA)
for their Abbreviated New Drug Applications (ANDAs) for Lamotrigine Tablets.
Genpharm also received final FDA approval for its ANDA for a separate
Lamotrigine product, Lamotrigine Tablets Chewable Dispersible (CD).
Mylan Pharmaceuticals' and Genpharm's ANDAs were approved for the 25 mg,
100 mg, 150 mg and 200 mg strengths of the generic version of
GlaxoSmithKline's Lamictal® Tablets. This product had annual U.S. sales of
approximately $2.5 billion for the 12 months ending Sept. 30, 2008, for the
same strengths according to IMS Health.
Genpharm's ANDA was approved for the 5 mg and 25 mg strengths of the
generic version of GlaxoSmithKline's Lamictal® CD Tablets. This product had
annual U.S. sales of approximately $91 million for the 12 months ending Sept.
30, 2008, for the same strengths according to IMS Health.
These products are used for the treatment of epilepsy and for maintenance
treatment of bipolar I disorder. Mylan will distribute both products
immediately and under the Mylan Pharmaceuticals 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 www.mylan.com.
SOURCE Mylan Inc.
01/28/2009
CONTACT: Michael Laffin (Media), +1-724-514-1968; or Dan Crookshank
(Investors), +1-724-514-1813
Web Site: http://www.mylan.com
(MYL)