Sun Pharma gets US FDA approval for alfuzosin generic

The Indian generic major Sun Pharmaceuticals received a tentative approval for its generic version of alfuzosin hydrochloride tablets.

Alfuzosin is an alpha 1 blocker used in the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Alfuzosin improves urine flow by relaxing the smooth muscle located at the bladder neck and around the prostate.

Alfuzosin hydrochloride pills is the therapeutically equivalent version of Sanofi-Aventis’ Uroxatral extended release tablets.

The US Food and Drug Administration have given tentative approval to the Abbreviated New Drug Application (ANDA) for alfuzosin hydrochloride 10 mg tablets submitted by Sun Pharma through its US subsidiary.

Benign prostatic hyperplasia (BPH) is the increase in size of the prostate in middle-aged and elderly men. It is characterized by hyperplasia of prostatic stromal and epithelial cells, resulting in the formation of large, fairly discrete nodules in the periurethral region of the prostate. Benign prostatic hyperplasia symptoms are classified as storage or voiding.

Voiding symptoms include weak urinary stream, needing to wait for the stream to begin, the stream starts and stops intermittently, straining to void,burning sensation in the urethra, and dribbling.

BPH can be a progressive disease. Incomplete voiding results in stasis of bacteria in the bladder residue and an increased risk of urinary tract infections.

Alfuzosin hydrochloride tablets have annual sales of approximately $180 million in the US, according to the release from Sun Pharma.

Established in 1983, listed since 1994, Sun Pharmaceutical Industries Ltd is a specialty pharmaceutical company. Sun manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world. In India, the company is a leader in niche therapy areas of psychiatry, neurology,cardiology, diabetology, gastroenterology, and orthopedics. The company has skills in product development, process chemistry, and manufacturing of complex API, as well as dosage forms.