Alembic Gets USFDA Nod for Drug

  Published 10 months ago

Alembic Pharma receives USFDA final approval for Carbamazepine ER tablets, a generic of Tegretol-XR, in multiple strengths.

  • Approved strengths include 100 mg, 200 mg, and 400 mg; used to treat seizures and trigeminal neuralgia pain.
  • The drug has a US market size of $71 million for the 12 months ending March 2025, per IQVIA.
  • Alembic now holds 225 total ANDA approvals from the USFDA, including 202 final and 23 tentative.

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