Generic version of Diovan from India approved by FDA
- Ranbaxy has overcome quality control issues and has gained approval for generic valsartan in the U.S. more than a year after Novartis’s patent expired.
- This is the first generic version of the blood pressure drug Diovan that will become available in the U.S.
- Ranbaxy will have six months of exclusivity.
It has taken more than a year for Ranbaxy to be able to market valsartan in the U.S, after being turned down last year due to quality issues related to manufacturing. The problem of quality control has been ongoing in India and well-publicized. Since 2009, four plants have been prohibited for a variety of reasons, including unsanitary conditions, from importing to the U.S.
Overcoming this problem is a huge step for a manufacturer in India, where 40% of all generic medications in the U.S. are manufactured.
- pharmafile.com Ranbaxy’s Diovan copycat approved in the US