Ranbaxy gets nod for Lisinopril
By Nisha Das | 24 Oct 2001
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.