Clinical Trials Not Required For Lidoderm Generics, FDA Tells Endo
The agency distinguishes the lidocaine pain patch from topical dermatological drugs intended to treat skin diseases in rejecting Endo’s call that ANDA sponsors demonstrate bioequivalence through clinical trials, rather than merely pharmacokinetic studies.
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Another outside candidate is expected to eventually take over for the departing director Gregory Geba, and while the Office of Generic Drugs can run smoothly without a permanent leader for now, it cannot do so forever.
Endo citizen petition asks FDA to determine that the company’s old formulation was withdrawn for safety reasons and to decline approval of ANDAs of that formulation; Purdue Pharma files third OxyContin citizen petition.
Endo’s lawsuit challenging the sufficiency of Mylan’s Paragraph IV notice was thrown out in its entirety. Mylan objects to Endo’s bid to amend its complaint, saying the brand company cannot now seek to invoke a 30-month stay.