Daiichi Sankyo-controlled Ranbaxy Laboratories sued the US
Federal Drug Authority (USFDA) for revoking approvals granted to it to launch
copies of two drugs—AstraZeneca’s Nexium and Roche AG's Valcyte, said reports.The
company argued in its suit before district court in Columbia, that the FDA's
move violated constitutional rights, exceeded the agency's statutory authority,
and was "arbitrary, capricious, and otherwise contrary to law. The FDA has
no power to correct an alleged mistake it made six years ago."However, the
company did not make any public statement.
Early November FDA revoked Ranbaxy’s tentative approval for
selling copycat low-cost versions of blockbuster heartburn drug Nexium and
antiviral drug Valcyte in US market.It said that FDA had made an error in
granting approval given the compliance status of the plants which were to
produce the generic versions of the blockbuster drugs.Further, the FDA allowed
Dr Reddy's along with US-based Endo for one of the above mention drugs Valcyte.
Valcyte is an antiviral medicine made by Roche.The move takes out a big revenue
earning potential for the Indian drugmaker, which was also seen as a critical
part of the proposed deal with Sun Pharma.
