Pharmaceutical and biotechnology major Wockhardt Limited today announced US FDA approval for marketing Furosemide injection in the US. Furosemide injection is one of the most widely used diuretics (drugs that promote excretion of urine) in hospitals and ICUs in several life-threatening conditions.
"Furosemide is our fourth injection to receive US FDA approval," Wockhardt chairman Habil Khorakiwala said. "Injectables are a key element of our US strategy. The regulatory process for approval of sterile injectables is complex and demanding, which limits the number of players in the market."
Over 35 million Furosemide vials, originally marketed under the brand name Lasix, are sold annually in the US alone. This is Wockhardt's second FDA approval in a week following the approval of painkiller Dextropropoxyphene + Acetaminophen tablets a few days ago.
Wockhardt's US subsidiary Wockhardt USA Inc.will be launching Furosemide injection in the US market soon. Over the last one year, Wockhardt USA has built relationships with large hospitals, group purchasing organisations and the managed care segment in the US to market its injectables.
This is Wockhardt's seventeenth ANDA (abbreviated new drug application) approval.
The development and manufacture of the dosage form and marketing in the US are all undertaken by Wockhardt, enabling the company to capture maximum value.
