Mylan Inc. announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the US 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 Flavour Packs), the generic version of Braintree Laboratories' NuLytely laxative.
Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution (with Flavour Packs) had US sales of approximately US$ 31 million for the 12 months ending December 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.