Pharmabiz
 

Mylan introduces finasteride tablets in US market

Hertfordshire, EnglandTuesday, August 2, 2016, 15:00 Hrs  [IST]

Mylan NV, a global pharmaceutical company, announced the US launch of finasteride tablets USP, 1 mg, a generic version of Merck's Propecia. Mylan received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in men only.

Finasteride tablets USP, 1 mg, had US sales of approximately $35.3 million for the 12 months ending May 31, 2016, according to IMS Health.

Currently, Mylan has 245 ANDAs pending FDA approval representing $101.6 billion in annual brand sales, according to IMS Health. Forty-one of these pending ANDAs are potential first-to-file opportunities, representing $30.8 billion in annual brand sales, for the 12 months ending December 31, 2015, according to IMS Health.

 
[Close]