Zydus Pharms gets FDA approvals for lacosamide labeling update and generic epinephrine injection
Zydus Pharms logged two FDA actions dated September 2026, a labeling supplement for its intravenous lacosamide and original approval for an epinephrine injection.
Zydus Pharms had two FDA approvals recorded for the week, one a labeling change and one a new generic.
- Zydus Pharms received approval of a labeling supplement (SUPPL 8) for its lacosamide intravenous solution, 200MG/20ML (10MG/ML), under ANDA209465, with a submission status date of 2026-09-17.1
- Zydus Pharms received original approval (ORIG 1) for an epinephrine injection solution, EQ 30MG BASE/30ML (EQ 1MG BASE/ML), for intramuscular, intravenous, and subcutaneous use, under ANDA219832, with a submission status date of 2026-09-14.2
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