14Oct 2023
Lupin Receives Tentative Approval from U.S. FDA for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution

Lupin Receives Tentative Approval from U.S. FDA for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution

Mumbai-based pharmaceutical company Lupin Limited has been granted provisional approval by the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) related to a generic version of Xywav@ Oral Solution, 0.5 g/mL, produced by Jazz Pharmaceuticals Ireland Limited. This medication, named Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution, 0.5 g/mL, will be manufactured at Lupin's facility in Somerset, United States to treat cataplexy or excessive daytime sleepiness.. Lupin's exclusive status as the first applicant for this generic version may afford it a 180-day exclusivity period upon product launch.

  • #family health

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