Lupin receives U.S. FDA approval for Amifampridine Tablets, 10 mg, and is eligible for 180-day shared generic exclusivity
Lupin Limited has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Applications for Amifampridine Tablets, 10 mg, announced on November 2, 2026.
By ScoutQuest · · 1 min read
- Approval Received
- United States Food and Drug Administration approval for Abbreviated New Drug Applications for Amifampridine Tablets
- Dosage
- 10 mg
- Reference Listed Drug
- Firdapse Tablets, 10 mg, of Catalyst Pharmaceuticals, Inc.
- Release
- Press release
📌 The company says Amifampridine Tablets, 10 mg are bioequivalent to the reference listed drug Firdapse Tablets, 10 mg, of Catalyst Pharmaceuticals, Inc., for the indication in the approved labeling.
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More numbers
- Shared generic exclusivity period, Amifampridine Tablets180 days
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