Mylan Receives FDA Approval for First-to-File Generic Depakote(R) ERCompany will have 180 days of marketing exclusivity on the 500 mg strength
PITTSBURGH, Jan. 30 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today
announced that its subsidiary Mylan Pharmaceuticals Inc. has received final
approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated
New Drug Application (ANDA) for Divalproex Sodium Extended-release (Divalproex
ER) Tablets, 250 mg and 500 mg.
Mylan has been awarded 180 days of marketing exclusivity for the 500 mg
strength, which it will begin to ship Feb. 2. Mylan was the first company to
file a substantially complete ANDA containing a Paragraph IV certification for
the 500 mg strength. Mylan is shipping the 250 mg strength immediately.
Divalproex ER Tablets are the generic version of Abbott Laboratories'
Depakote® ER and had U.S. sales of approximately $901 million for the 12
months ending Sept. 30, 2008, with $789 million for the 500 mg strength and
$112 million for the 250 mg strength.
Currently, Mylan has 119 ANDAs pending FDA approval, 33 of which are
potential first-to-file opportunities.
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.
SOURCE Mylan Inc.
01/30/2009
CONTACT: Michael Laffin (Media), +1-724-514-1968, or Dan Crookshank
(Investors), +1-724-514-1813, both of Mylan Inc.
(MYL)