Generic Unithroid approval
Executive Summary
FDA approves Mylan ANDA for Jerome Stevens' Unithroid (levothyroxine) on June 5. Jerome Stevens is seeking $1.3 bil. from FDA for allegedly posting trade secrets from its NDA, approved in August 2000, on the agency website (1"The Pink Sheet" April 1, In Brief)...
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Levothyroxine Review Standards Should Be Same For ANDAs, Brands – Petition
Levothyroxine generics should be held to the same review standards as their 505(b)(2) counterparts, Unithroid manufacturer Jerome Stevens maintained in a 1citizen petition to FDA
User fee increase coming?
Jerome Stevens Pharmaceuticals is seeking $1.3 bil. from FDA for the agency's "unlawful publication of trade secrets and confidences" for Unithroid on its web site, the company announces March 26. The claim approaches the agency's $1.7 bil. annual operating budget. FDA posted trade secrets from its October 1999 levothyroxine NDA from Aug. 22, 2000 to Jan. 23, 2001, the company said. JSP will sue the agency in D.C. federal court if FDA fails to act on the tort claim within six months...
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