Ranbaxy Laboratories’ tentative approvals for its generic versions of digestive disorder drug Nexium and antiviral Valcyte along with 180-day marketing exclusivity stands cancelled following a U.S. court decision.
The DC Federal Court in the U.S. has upheld the decision of the USFDA for rescinding tentative approvals given to it for generic digestive disorder drug Nexium and antiviral Valcyte.
“The court has now issued an opinion indicating that it was (i) denying Ranbaxy’s request for preliminary injunction and (ii) granting defendants’ requests for summary judgement on the merits,” Ranbaxy Laboratories said in a filing to BSE.
In effect, the company further said, “The court’s decision upheld the status quo that FDA had created by rescinding Ranbaxy’s tentative approvals and forfeiting our 180-day exclusivities on Valganciclovir and Esomeprazole in November, 2014.”
In November, Ranbaxy had sued USFDA over revoking an approval to sell generic versions of Nexium and Valcyte in the U.S. and had also requested the court for a temporary restraining order asking the regulator not give approvals for ANDAs of other companies for the two drugs.
The court had not earlier granted the company temporary restraining order to block the health regulator from approving other ANDAs for generic versions of the two drugs.
