Ivax to join Zocor court battle
Ivax files suit against FDA on Nov. 7 claiming exclusivity rights for Merck's cholesterol-lowering agent Zocor (simvastatin) following an Oct. 24 letter from the agency denying its citizen petition. Ivax claims exclusivity rights for Zocor 5 mg, 10 mg, 20 mg and 40 mg strengths and seeks to have two Merck patents re-listed in the "Orange Book." Ranbaxy filed suit against FDA Sept. 16 claiming exclusivity rights for the 80 mg dose of Zocor (1"The Pink Sheet" Oct. 31, 2005, p. 19). Both Ivax and Ranbaxy need a quick win to settle the matter; the compound patent for Zocor is set to expire June 23, 2006...
You may also be interested in...
Ranbaxy needs a relatively quick win in its lawsuit against FDA if it hopes to benefit from the 180-day exclusivity it is claiming for Zocor 80 mg
Early results from its novel antiviral are encouraging, but demonstrating life-saving qualities in a short window of time will be tricky.
After federal agencies invested almost $5600m to ensure Cue Health could scale up production, FDA announces the self-administered test will be available OTC. it's the agency's first emergency use authorization for an at-home molecular diagnostic test available nonprescription.