FDA requests CMC data on Lundbeck's Carbella application

25 October 2014

Danish CNS drug specialist Lundbeck (LUND: CO) says that it has received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding its New Drug Application seeking approval of Carbella (carbamazepine) injection.

Carbella is an investigational intravenous formulation of the anti-epileptic drug (AED) carbamazepine. Lundbeck is currently addressing requests specified in the letter, and is committed to making Carbella available in 2015, pending FDA approval, the company stated.

The Complete Response Letter only requested additional Chemistry, Manufacturing and Controls (CMC) data. Carbamazepine has been licensed by Lundbeck from US drugmaker Ligand Pharmaceuticals (Nasdaq: LGND).

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