Mylan Receives Approval for Generic Version of GoLytely(R)
30 January 2010 - 2:38AM
PR Newswire (US)
PITTSBURGH, Jan. 29 /PRNewswire-FirstCall/ -- Mylan Inc.
(NASDAQ:MYL) today announced that its subsidiary Mylan
Pharmaceuticals Inc. received final approval from the U.S. Food and
Drug Administration (FDA) for its Abbreviated New Drug Application
(ANDA) for Polyethylene Glycol 3350 and Electrolytes for Oral
Solution, USP, the generic version of Braintree Laboratories'
GoLytely® laxative. Polyethylene Glycol 3350 and Electrolytes for
Oral Solution had U.S. sales of approximately $14 million for the
12 months ending Sept. 30, according to IMS Health. Mylan's version
is available for immediate shipment. Currently, Mylan has 141 ANDAs
pending U.S. Food and Drug Administration approval representing
$87.9 billion in annual brand sales, according to IMS. Thirty-nine
of these pending ANDAs are potential first-to-file opportunities,
representing $19.6 billion in annual brand sales, according to IMS.
Mylan Inc. ranks among the leading generic and specialty
pharmaceutical companies in the world and provides products to
customers in more than 140 countries and territories. The company
maintains one of the industry's broadest and highest quality
product portfolios supported by a robust product pipeline; operates
one of the world's largest active pharmaceutical ingredient
manufacturers; and runs a specialty business focused on
respiratory, allergy and psychiatric 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 Web Site:
http://www.mylan.com/
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