New Delhi: Drug major Sun Pharmaceutical has withdrawn its appeal in the lawsuit filed by Ranbaxy against the US health regulator challenging FDA’s decision to revoke approvals for generic versions of Nexium and Valcyte.
“Company has withdrawn its appeal in the lawsuit filed by erstwhile Ranbaxy Laboratories Ltd in November 2014 in a US District Court against US Food and Drug Administration,” Sun Pharma said in a regulatory filing today.
The lawsuit challenged FDA’s revocation of Ranbaxy’s tentative approvals for its generic versions of Nexium and Valcyte in the US, it added.
“The company do not believe that the withdrawal of said lawsuit by Sun Pharma will have any materially adverse financial impact on the company,” the statement added.
As per the lawsuit filed in the US District Court of Columbia in November 2014, Ranbaxy had sought “immediate judicial review” of a November 4 decision of the USFDA that stripped it of statutory rights and “literally hundreds of millions of dollars in anticipated revenues for certain generic versions of the brand-name drugs Nexium and Valcyte”.
In 2008, Ranbaxy was granted approval by the USFDA to sell its generic copies in select doses of Astrazaneca’s Nexium and Roche’s Valcyte as and when the patents of the two branded drugs expired.
However, the company had run into trouble with the USFDA cracking down on it for failure to observe current GMPs (good manufacturing practices) at its Dewas and Paonta facilities.
In March, Sun Pharma completed the USD 4-billion merger of Ranbaxy with itself.
Sun Pharma’s shares were trading at Rs 907.20 in afternoon trade on BSE, down 0.91 per cent from previous close.