The Hindu Business Line : Wockhardt drug gets tentative nod

Wockhardt Ltd has received tentative approval from the United States Food and Drug Administration (USFDA) to sell anti-epileptic drug Divalproex Sodium delayed release tablets in the US.

Divalproex Sodium is the generic version of Abbott's Depakote DR tablets and the patent on the product expires on January 29, 2008.

Wockhardt USA Inc, a subsidiary of the Mumbai-based drug-maker will launch the product on the first day of patent expiration in the US market, a note from the company said. The market for the product in the US is $802 million.

The Wockhardt Chairman, Mr Habil Khorakiwala, said that the approval (when it comes) would be the company's third US FDA approval in three weeks and the fifth this year. Wockhardt has 20 more products awaiting US FDA approval, he said. Divalproex Sodium will be manufactured at Wockhardt's bulk-drug facility at Ankleshwar and the tablets will be manufactured at the formulation plant in Aurangabad, both certified by US FDA.

More Stories on : Regulatory Bodies & Rulings | Pharmaceuticals | Health

Article E-Mail :: Comment :: Syndication :: Printer Friendly Page

Stories in this Section
Suzuki Motor Corp to use India as export hub

HC fixes June 21 for hearing of appeal by Lodha

Nod for Vivimed $75-m global offer

HZL bags `Golden Peacock' award

India Inc most optimistic on hiring, says survey

Carborundum to take 49 pc stake in Chinese co

Italcementi to invest Rs 800 cr

Natural gas to RNRL: Details sought from RIL

Wockhardt drug gets tentative nod

Ciba Specialty, Virchow Group to form joint venture

L&T inks jt venture agreement in Kuwait

S.P. Apparels chalks out Rs 150-cr capex plan

Regency Ceramics pins hopes on gas in K-G basin

Focus on local manpower in Assam Gas Cracker project

Pratibha Syntex to raise Rs 350 cr for expansion