India'a largest pharmaceutical company Ranbaxy Laboratories Ltd has finally got nod from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) and Quinapril Hydrochloride & Hydrochlotothiazide (Quinapril + HCTZ) Tablets, an ACE inhibitor which is used to treat high blood pressure.
The company received approval for tablets in strength of 10mg/12.5mg, 20 mg/12.5mg and 20mg/225mg respectively.
An official release stated that, the office of Generic Drugs, USFDA, had determined the Ranbaxy formulations to be bioequivalent and as having the same therapeutic effect as that of the reference listed drug, Accuretic Tablets of Pfizer Pharmaceuticals Ltd.
It should be noted that this is the second ANDa approval granted by the USFDA, to Ranbaxy, in the last two months.
The application for the drug was submitted by Ranbaxy, from OHM Laboratories manufacturing facility, at New Jersey, USA.
Latest News
|
|
|
|
|
|
|
|
|
|
|
|
Popular content
Today's:
All time:
Last viewed:
- Apple rolls out new versions of its iMac, Mac Pro and Mac Mini computers
- Men with long ring finger tend to be speed demon
- Nutritional Claims Targeted by FDA on Food Packaging
- Prison likely for fake aircraft mechanic
- Facebook finds democratic way to win over its users
- Mexican billionaire Slim to invest $250 million in NY Times
- Australian share market falls 2.69% due to sharp falls on Wall Street
- GM to file for bankruptcy early Monday
- U.S. Mortgage Applications Increase
- Intel alleges AMD of breaching the x86 cross-license agreement
US Business News
- Sony Ericsson shifts HQ from NC to Atlanta; closes a few other sites worldwide
- Microsoft: No-cost Azure service launches in January; to be charged for in February
- Rolls Royce and Air China Close $1.5 Billion Deal for New Engines
- Missouri Plant Work Dispute Resolved by Ford and UAW
- MUFG Looking to Raise $11 Billion Through Public Offering of Common Shares
