Generic version of tamsulosin for BPH granted FDA approval

March 25, 2010

The FDA has approved the first generic version of tamsulosin hydrochloride capsules, 0.4 mg, to treat BPH.

The FDA has approved the first generic version of tamsulosin hydrochloride capsules, 0.4 mg, to treat BPH.

"The approval of generic tamsulosin offers greater access to a widely used treatment for BPH," said Gary Buehler, RPh, of the FDA’s Office of Generic Drugs. "FDA is committed to making generic drugs available to patients and these drugs meet the same rigid standards as the brand name drugs."

The prescribing information and safety warnings for the generic version of tamsulosin are the same as those for the brand-name version. Generic tamsulosin capsules are manufactured by IMPAX Laboratories, Inc., of Hayward, CA.