Final FDA appro for Mylan's finasteride
Mylan Pharmaceuticals has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for finasteride tablets USP, 5mg. This is a generic version of Merck & Co's Proscar, which is approved for the treatment of symptomatic benign prostatic hyperplasia in men with an enlarged prostate to improve symptoms and reduce the risk of the need for surgery including transurethral resection of the prostate and prostatectomy.
Total US sales for the 5mg strength of finasteride were around $553.0 million for the 12-month period ended September 30, according to data from IMS Health. This generic product will be shipped immediately, says Mylan.
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