Mylan Receives Approval for Generic Version of NuLytely(R)
PITTSBURGH, April 7 /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, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution (with Flavor Packs), áthe generic version of Braintree Laboratories' NuLytely« laxative.
Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution (with Flavor Packs) had U.S. sales of approximately $31 million for the 12 months ending Dec. 31, 2009, according to IMS Health. Mylan's version is available for immediate shipment.
Currently, Mylan has 144 ANDAs pending FDA approval representing $96.7 billion in annual brand sales, according to IMS Health. Thirty-nine of these pending ANDAs are potential first-to-file opportunities, representing $19.8 billion in annual brand sales, for the 12 months ending December 31, 2009, according to IMS Health.
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 www.mylan.com.
SOURCE Mylan Inc.