30-Month Stay Disputed In Endo’s Lidoderm Litigation With Mylan
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.
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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.
FDA will not decide whether the first-filer is entitled to 180 days of marketing protection until another ANDA is ready for full approval. Watson “believes” it holds marketing exclusivity for Endo’s pain patch even though it failed to obtain tentative approval within the statutory 30-month timeframe.
Agency wants to ensure patients ‘aren’t unnecessarily or unfairly scared off or intimidated’ from taking biosimilars, Office of Therapeutic Biologics and Biosimilars' acting policy director Eva Temkin tells the FDA/CMS Summit; Temkin says recent guidance on biosimilar insulins shows agency is trying to be flexible on interchangeability data requirements.