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Lundbeck provides update on new drug application for intravenous carbamazepine

Lundbeck has received a Complete Response Letter from the US Food and Drug Administration (FDA) for its New Drug Application seeking approval of Carbella (carbamazepine) injection, 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.

"We are working closely with the FDA to address the Complete Response Letter, and hope to bring Carbella to market in the coming year."

The Complete Response Letter only requested additional Chemistry, Manufacturing and Controls (CMC) data.

"Within the past five years, Lundbeck advanced to market multiple products for people living with challenging seizure types, which is a reflection of our company’s commitment to the epilepsy community," said Staffan Schüberg, president of Lundbeck in the U.S.

"We are working closely with the FDA to address the Complete Response Letter, and hope to bring Carbella to market in the coming year."

Carbella is an investigational intravenous formulation of carbamazepine. Oral carbamazepine first received FDA approval in 1968. Lundbeck received orphan drug designation for Carbella from the FDA in 2013.

Lundbeck submitted a New Drug Application for Carbella in March 2014. Carbella is proposed for use as replacement therapy in adults who are on a stable maintenance oral dose of carbamazepine to control certain seizure types, when oral carbamazepine administration is temporarily not feasible and is expected to have a similar safety profile to oral carbamazepine.