FDA Grants ANDA Approval for ICATIBANT (ANDA213773)

The U.S. Food and Drug Administration (FDA) has issued an approval for application number ANDA213773 for the drug ICATIBANT. ICATIBANT (generic name ICATIBANT, substance ICATIBANT ACETATE) is a prescription injectable administered subcutaneously. The product is listed as an injectable dosage form with strength EQ 30 mg base per 3 mL (EQ 10 mg base per mL). NDC codes include 46708‑654‑03, 46708‑654‑09, 62332‑654‑03, and 62332‑654‑09. The drug is manufactured by Alembic Pharmaceuticals Limited and Alembic Pharmaceuticals Inc., under the sponsor name ALEMBIC. The submission was an original (ORIG) filing, reviewed with standard priority, and the status was listed as “AP” on June 14, 2024.