Apr 8 2010
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), the 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.