Wockhardt receives USFDA approval for tablet

Bangalore, June 1: Pharmaceutical and biotechnology major Wockhardt Limited has received approval from the United States Food and Drug Administration (USFDA) for marketing Clarithromycin tablets in the US market.

Wockhardt's US subsidiary, Wockhardt USA Inc, was expected to launch the broad-spectrum macrolide antibiotic within the next two weeks. As per IMS data, the current market for this product in the US was US Dollar 113 million, according to a company release here today.

''This is our second ANDA approval in the last two weeks, and our fourth this year. With more approvals expected in the second half of 2006, we will have a healthy basket of products in the US,'' Wockhardt Chairman Habil Khorakiwala said.

Clarithromycin, the generic version of Abbott's Biaxin tablets, was manufactured at the active pharmaceutical ingredient facility at Ankleshwar and the tablets were manufactured at the formulation unit at Aurangabad, both USFDA approved plants. The process for the API and the tablet were developed through in-house research, the release said.

With Clarithromycin, Wockhardt now had 13 products in the US market, compared to five last year. It had over 20 products awaiting USFDA approval.

UNI