India’s Wockhardt has received tentative approval from the United States Food & Drug Administration (US FDA) for a generic version of alfuzosin, a drug used in the treatment of prostate disease.
Wockhardt got tentative approvals for its abbreviated new drug application (ANDA) for marketing alfuzosin hydrochloride extended release tablets in 10mg strengths, the company said in a press note.
Wockhardt’s alfuzosin hydrochloride extended release tablets are the generic version of , the brand Uroxatral, marketed in the United States by Sanofi-Aventis.
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 extended release tablets are used for treating benign prostatic hyperplasia (BPH or non-cancerous enlargement of prostate). Alfuzosin is the generic name for the brand Uroxatral, marketed in the United States by Sanofi-Aventis.
Patents covering alfuzosin hydrochloride extended release tablets are under litigation in the US courts.
Wockhardt is planning to launch alfuzosin hydrochloride extended release generic tablets after resolution of the patent dispute, the release stated.
The total market for alfuzosin tablets in the US is about $203 million, according to IMS Health.
No generic version of alfuzosin hydrochloride extended release tablets has been launched so far in the United States.
“This is the second modified-release product approval for Wockhardt in the past five days and our fourth this year,” said Wockhardt Chairman Habil Khorakiwala.
Wockhardt will manufacture alfuzosin tablets at the US FDA certified formulation plant at Waluj in Aurangabad. Alfuzosin hydrochloride API will be sourced from Wockhardt’s US FDA approved plant. Both the API and the tablets were developed in-house.
In May, Indian generic major Sun Pharmaceuticals received a tentative approval for its generic version of alfuzosin hydrochloride 10 mg tablets.
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.
Headquartered in Mumbai Wockhardt has 5 research centres and 14 manufacturing plants dotting various countries and continents that are compliant to international regulatory standards such as the US FDA, MHRA and other global regulatory bodies.
Wockhardt has end-to-end integrated capabilities for its products, starting with manufacture of the oral and sterile API’s, the dosage forms and marketing through its wholly owned subsidiary in the US.