Sun Pharma withdraws law suit filed by Ranbaxy challenging the FDA
Sun Pharma is reported to have officially withdrawn the law suit filed by Ranbaxy against the FDA’s decision to revoke approvals for the generic version of Nexium and Valcyte. In March, Sun Pharma completed the $4-billion merger of Ranbaxy with itself.
Ranbaxy had earlier received an approval from the FDA to manufacture select doses of the said two drugs: only after the patents of these two branded drugs would expire. However, the million dollar anticipated revenue investment turned against Ranbaxy after the FDA revoked its decision; due to the failure of the company to observe current GMPs (good manufacturing practices) at its Dewas and Paonta facilities.
"Company has withdrawn its appeal in the lawsuit filed by erstwhile Ranbaxy Laboratories Ltd in November 2014 in a US District Court against US Food and Drug Administration," Sun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".
Ranbaxy had earlier received an approval from the FDA to manufacture select doses of the said two drugs: only after the patents of these two branded drugs would expire. However, the million dollar anticipated revenue investment turned against Ranbaxy after the FDA revoked its decision; due to the failure of the company to observe current GMPs (good manufacturing practices) at its Dewas and Paonta facilities.
"Company has withdrawn its appeal in the lawsuit filed by erstwhile Ranbaxy Laboratories Ltd in November 2014 in a US District Court against US Food and Drug Administration," Sun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".
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