WASHINGTON — Jazz Pharmaceuticals lost its bid to overturn the approval of another company’s rival sleep drug when a D.C. federal judge ruled that the FDA did not violate the Orphan Drug Act when determining that the two narcolepsy treatments were not the same. Avadel Pharmaceuticals’ Lumryz only requires one dose prior to sleep, while Jazz’s Xywav requires a second dose within four hours, breaking up the sleep cycle. The FDA found Lumryz to be “clinically superior” to Xywav, allowing it to be approved during Xywav’s exclusivity period.
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