DEERFIELD, Ill.--(BUSINESS WIRE)--Lundbeck LLC announced today that it has received a Complete Response Letter from the U.S. 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.
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.”
About Carbella (carbamazepine)
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.
About Lundbeck in the U.S.
Lundbeck in the U.S., headquartered in Deerfield, Illinois, is a wholly-owned subsidiary of H. Lundbeck A/S in Denmark. Globally, our mission is to help people suffering from psychiatric and neurologic disorders. To drive this mission in the U.S., nearly 800 employees are engaged in the research, development, production, marketing and sale of innovative specialty therapies that fulfill unmet medical needs. We see the person behind the disease and how it affects the lives of patients, families and caregivers. Lundbeck is actively involved with hundreds of local and national U.S. events each year that support our patient communities. To learn more, visit us at www.LundbeckUS.com and connect with us on Twitter at @LundbeckUS.
About H. Lundbeck A/S
H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in brain diseases. For more than 50 years, we have been at the forefront of research within neuroscience. Our development and distribution of pioneering treatments continues to make a difference to people living with brain diseases. Our key areas of focus are alcohol dependence, Alzheimer’s disease, depression/anxiety, epilepsy, Huntington’s disease, Parkinson’s disease, schizophrenia and stroke.
Our nearly 6,000 employees in 57 countries are engaged in the entire value chain throughout research, development, production, marketing and sales, and are committed to improving the quality of life of people living with brain diseases. Our pipeline consists of several late-stage development programs and our products are available in more 100 countries. We have research centers in China, Denmark and the United States, and production facilities in China, Denmark, France, Italy and Mexico. Lundbeck generated revenue of approximately DKK 15 billion in 2013 (EUR 2.0 billion; USD 2.7 billion).