FDA approves Dainippon's original anti-epileptic drug, Zonegran® (generic name: zonisamide) in the U.S.
March 30, Dainippon Pharmaceutical Co. Ltd (Head office: Osaka, President: Kenjiro Miyatake) today announced the approval by the Food and Drug Administration (FDA) of the New Drug Application for its original anti-epileptic drug zonisamide in the United States.
The number of people suffering from epilepsy in the U.S. is estimated to be more than 2 million, and thirty percent do not have sufficient control with currently available anti-epileptic drugs. The indication for this drug is adjunctive therapy for refractory cases with partial seizures not controlled by existing drugs.
In the US, Dainippon started the development by contracting with a CRO in 1992, and an NDA was filed with the FDA in March, 1997.From July of the same year, Elan Phamaceuticals of North America, a division of Elan Corporation plc, has been licensed to sell the product in the U.S., and has been in contact with the FDA on behalf of Dainippon, and received approvable letters issued by the FDA. Elan Phamaceuticals will launch the drug in the U.S. under the trade name of Zonegran® in April, 2000. Zonegran® will be available in local pharmacies in May.
Zonisamide is an anti-epileptic drug originating from the investigation of a series of benzisoxazole compounds, and has been available in Japan since 1989 under the trade name of Excegran.
Dainippon has long been involved in the treatment of epilepsy by marketing a variety of anti-epileptic drugs, since the launch of its first anti-epileptic drug Aleviatin (phenytoin) in 1940. In 1987, as part of the celebrations for its 90th anniversary, Dainippon established the Japan Epilepsy Research Foundation (Director-General: Tomio Fujiwara), and continues to support research for the treatment of epilepsy.
Profile of Elan Corporation
Company name: Elan Corporation plc
Head Office: Ireland
President: Donal J. Geaney
Corporate Activity: International pharmaceutical company. Principal research and
manufacturing facilities in Ireland, United States and Israel.
Profile of Elan Pharmaceuticals of North America (formerly Athena Neuroscience Co.)
Company name: Elan Pharmaceuticals of North America
Head Office: California, United States
President: Michael D. Coffee
Corporate Activity: Wholly-owned subsidiary of Elan Corporation plc (Ireland), specializes in the field of neuroscience and the biomedical industry. For sales in the neuroscience area, both in quality and amount, it is ranked as one of the top 5 companies in the US market.