Ranbaxy gets nod for Lisinopril

Mumbai: Ranbaxy Pharmaceuticals Inc, a wholly-owned subsidiary of pharma major Ranbaxy Laboratories Ltd, has announced that the company has received tentative approval from the USFDA for Lisinopril tablets for dosages in the 2.5 mg, 5mg, 10 mg, 20 mg and 40 mg range. A company statement said that studies have shown Lisinopril to be the bio-equivalent and therapeutical equivalent of ZestrilO tablets.

Lisinopril is indicated for the treatment of hypertension, either alone as part of initial therapy or concomitantly with other classes of anti-hypertensive agents. It is also indicated as adjunctive therapy in the management of heart failure and is prescribed to patients who do not respond adequately to diuretics and digitalis.

Additionally, Lisinopril is indicated for the treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction, to improve chances of survival. It is recommended that patients should receive, as appropriate, the standard recommended treatment such as thrombolytics, aspirin and beta-blockers.

Ranbaxy said that the tentatively approved formulation is the result of wide-ranging research and development (R&D) efforts, which focused on the Active Pharmaceutical Ingredient and the bio-equivalent formulation, both of which were developed by Ranbaxy Labs. The final dosage form will be manufactured and packaged at Ohm Laboratories, in the US (another wholly-owned subsidiary of Ranbaxy Laboratories Ltd) and will ultimately be marketed through Ranbaxy Pharmaceuticals Inc.