FDA Approves Mylan’s Yasmin Copies
Following approval from the US Food and Drug Administration (FDA), Netherlands-domiciled Mylan has launched generic copies of Bayer's drospirenone and ethinyl estradiol-based contraceptive tablets sold under the Yasmin brand name.
It is Mylan’s thirteenth launch of a generic oral contraceptive on the US market.
The application made by Mylan’s partner Famy Care was greenlighted under the FDA’s Abbreviated New Drug Application (ANDA) scheme.
US brand sales of the 3 mg/0.03 mg tablets totaled about $137.6 million for the 12 months ending June 30, 2015, according to figures released by IMS Health.
Currently, Mylan has 266 ANDAs pending FDA approval, representing $99.5 billion in annual brand sales. Some 50 of the pending ANDAs are said to be potential first-to-file opportunities, with a brand sales value of $33.4 billion.
