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Sun Pharma Receives FDA Nod For Generic Flomax

Sun Pharmaceutical has received an approval for its abbreviated new drug application (ANDA) to market a generic version of Flomax, Tamsulosin capsules.

Tamsulosin hydrochloride extended-release capsules are marketed under the trade names Flomax, Flomaxtra and Urimax, though generic non-modified release capsules are still approved and marketed in many countries, such as Canada.

Sun Pharma said that the Tamsulosin hydrochloride capsules, 0.4mg are therapeutically equivalent to Flomax Capsules 0.4mg from Boehringer Ingelheim Pharmaceuticals.

Tamsulosin is used in men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia or BPH) which include difficulty urinating (hesitation, dribbling, weak stream, and incomplete bladder emptying), painful urination, and urinary frequency and urgency.

Tamsulosin is in a class of medications called alpha blockers. It works by relaxing the muscles in the prostate and bladder so that urine can flow easily.

Flomax is a registered trademark of Astellas Pharma.