FDA Approves First Prostate Generic

2 March 2010 (Last Updated March 2nd, 2010 18:30)

The US Food and Drug Administration (FDA) has approved the first generic version of Flomax, used to treat benign prostatic hyperplasia (BPH), a condition where an enlarged prostate gland causes problems with urination. The generic tamsulosin capsules, manufactured by IMPAX Laboratories

The US Food and Drug Administration (FDA) has approved the first generic version of Flomax, used to treat benign prostatic hyperplasia (BPH), a condition where an enlarged prostate gland causes problems with urination.

The generic tamsulosin capsules, manufactured by IMPAX Laboratories, will provide patients with greater access to the treatment for BPH, which affects more than half of men in their 60s and as many as 90% of men older than 70.

FDA Office of Generic Drugs director Gary Buehler said that these drugs meet the same rigid standards as the brand-name drugs.

"The approval of generic tamsulosin offers greater access to a widely used treatment for BPH," said Buehler.

Flomax was originally developed by Boehringer Ingelheim and marketed in co-operation with Astellas.

India's Ranbaxy Laboratories was also scheduled to release their own generic version of Flomax in the US this month but have had to withdraw after not receiving the FDA's clearances on time.