FDA tentatively approves Flomax generic

HAYWARD, Calif. A specialty pharmaceutical company announced the tentative approval of its benign prostatic hyperplasia treatment.

Impax Laboratories Inc. confirmed that the Food and Drug Administration has granted tentative approval of the company’s abbreviated new drug application for a generic version of Flomax (tamsulosin hydrochloride) 0.4mg capsules. Boehringer Ingelheim Pharmaceuticals markets Flomax for the functional symptoms of benign prostatic hyperplasia.

According to Wolters Kluwer Health, U.S. sales of Flomax 0.4mg capsules were approximately $1.9 billion for the 12 months ended Aug. 31.