Ranbaxy Gets Fda Nod To Market Lisinopril In Us

Ranbaxy Pharmaceuticals Inc, a wholly owned subsidiary of Ranbaxy Laboratories Ltd in the US, has received tentative approval from the US FDA for the commercialisation of lisinopril, a drug indicated in the treatment of hypertension, in the US.

Lisinopril sales in the US totalled $1.2 billion, during 2000. Lisinopril has been sold under two brands in the US market, of which Zestril, a registered trademark of Astra Zeneca UK Ltd, sales accounted for $0.66 billion. As per a Ranbaxy release, based on kinetic studies, its lisinopril is deemed to be a bio- and therapeutic-equivalent of Zestril.

Ranbaxy has also filed an ANDA application with the US FDA for lisinopril with hydrochlorithizide. "Both the single entity and combination products are under patent production until December 2001, and intellectual property protection will be extended until June 2002, due to a pediatric exclusivity granted to the innovator(s)," the release said.

 

Lisinopril is used in the cure of hypertension, either alone, as initial therapy, or concomitantly, with other classes of anti-hypertensive agents. It is also indicated as adjunctive therapy in the management of heart failure. In addition, lisinopril is indicated for the treatment of hemodynamically stable patients within 24 hours of acute myocardial infraction to improve survival.

The tentatively-approved formulation is the result of research & development efforts which focused on the active pharmaceutical ingredient and the bio-equivalent formulation, both of which were developed by Ranbaxy in India.

The final dosage form will be manufactured and packaged in the US by Ohm Laboratories, another wholly owned Ranbaxy subsidiary, and marketed through the sales and marketing organisation of Ranbaxy Pharmaceuticals Inc. Ranbaxy plans to launch the product in June 2002. "It will be offered to all retail pharmacy outlets, wholesalers, hospitals and generic distributors throughout the US," the release said.