Amneal Loses Bid For 180-Day Generic Exclusivity On Namenda XR
US FDA's demand for commercial-scale data for memantine extended-release during ANDA review did not amount to change in 'requirements for approval,' judge rules, upholding agency determination that Amneal forfeited marketing exclusivity for failure to obtained tentative approval within 30 months.
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However, FDA must explain why denial of Sensipar's pediatric exclusivity was consistent with exclusivity award for J&J's Ortho Tri-Cyclen, US judge says. In swipe at plaintiff Amgen, court says pediatric study reports themselves guide exclusivity determinations, not the amount of effort a sponsor puts into those studies.
Amneal’s Namenda XR lawsuit asserts FDA’s determination that it forfeited 180-day marketing exclusivity on memantine extended-release generics ignores delays resulting from agency’s unexpected request for data from commercial-size lots.
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