Impax Labs receives FDA approval for generic tamsulosin

ROCKVILLE, Md. The Food and Drug Administration has approved the first generic version of a drug for treating enlarged prostate gland, the agency announced Tuesday.

The FDA approved Impax Labs’ tamsulosin hydrochloride capsules in the 0.4-mg strength, a generic version of Flomax, marketed by Boehringer Ingelheim and Astellas.

The drug is used to treat benign prostatic hyperplasia, a condition common in elderly men that enlarges the prostate and causes difficulty urinating.

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

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