Wockhardt Ltd has been granted US FDA approval for marketing furosemide injections in the US. Injectible furosemide is a widely used diuretic (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," Habil Khorikiwala, chairman, Wockhardt Ltd, 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.
The company's US subsidiary Wockhardt USA Inc. will be launching furosemide injections in the US market soon. Over the last one year, the subsidiary has built relationships with large hospitals, group purchasing organisations and the managed care segment in the US to market its injectables.
This is the Wockhardt's 17th ANDA (abbreviated new drug application) approval.
The company will handle the development and manufacture of the dosage form and marketing in the US.