17 abstracts accepted, including new and encore data emphasizing clinical benefit and patient preference for a once-at-bedtime narcolepsy treatment option Company to host symposium on October...
Avadel Pharmaceuticals fired up its marketing engine and debuted advertising for its narcolepsy drug Lumryz just weeks after its full FDA approval in May. But it wasn’t exactly the quick turn it might seem, as the biopharma was working for months in anticipation after Lumryz’s tentative approval last July.
BRIDGEWATER, N.J.--(BUSINESS WIRE)--Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced the launch of its authorized generic for Xyrem®1 (Sodium Oxybate) oral solution CIII in the United States. Sodium Oxybate oral solution, 0.5 g/mL is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients seven years of age and older with narcolepsy. In addition, the Company announced it has received Abbreviated New Drug Application (ANDA) approvals from the U.S. Food and Drug Administration (“FDA”) for five complex generics products. Three recently approved products are injectables, including dexmedetomidine injection which is currently on the U.S. FDA shortage product list.
After years of using the patent system to delay competition from a rival company and then exhausting that ploy early this year, Jazz Pharmaceuticals is taking a new route—suing the FDA.
DUBLIN, Ireland, June 22, 2023 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that...
Avadel Pharmaceuticals Announces U.S. Commercial Launch of LUMRYZ (sodium oxybate) for the Treatment of Cataplexy or Excessive Daytime Sleepiness in Adults Living with Narcolepsy
Avadel Pharmaceuticals notched an FDA approval for narcolepsy drug Lumryz on Monday following a multi-year court battle with Jazz Pharmaceuticals.
Avadel Pharmaceuticals Lumryz (sodium oxybate) Receives Approval in the U.S.A
- Granted Orphan Drug Exclusivity through May 1, 2030 - -Advanced commercial preparations on track; LUMRYZ product availability expected in early June - - Final approval supported by robust efficacy...