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 and Electrolytes for Oral Solution, USP, the generic version of Braintree Laboratories' GoLytely laxative.
Polyethylene Glycol 3350 and Electrolytes for Oral Solution had US sales of approximately US$ 14 million for the 12 months ending September 30, according to IMS Health. Mylan's version is available for immediate shipment.
Currently, Mylan has 141 ANDAs pending US FDA representing US$ 87.9 billion in annual brand sales, according to IMS. Thirty-nine of these pending ANDAs are potential first-to-file opportunities, representing US$ 19.6 billion in annual brand sales, according to IMS.
Mylan ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories.