Mylan Inc subsidiary Mylan Pharmaceuticals Inc has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Tamsulosin Hydrochloride Capsules USP, 0.4 mg, the generic version of Boehringer Ingelheim's benign prostatic hyperplasia (BPH) treatment, Flomax.
Tamsulosin Hydrochloride Capsules had US sales of approximately US$ 2.2 billion for the 12 months ending December 31, 2009, according to IMS Health. Mylan has started shipping this product.
Currently, Mylan has 139 ANDAs pending US FDA approval representing US$ 96.2 billion in annual brand sales, according to IMS Health. Thirty-seven of these pending ANDAs are potential first-to-file opportunities, representing US$ 19.6 billion in annual brand sales, for the 12 months ending December 31, 2009, according to IMS Health.