Eisai's Aciphex (rabreprazole sodium) has met the FDA's Written Request requirements for pediatric exclusivity in US.
Having met FDA's requirement, the company has now gained an additional 6 months US market exclusivity for Aciphex, which will expire on 8 November 2013.
The granting of pediatric exclusivity does not approve Aciphex to be used in pediatric patients, according to the company.
The company's New Drug Application for Aciphex delayed-release sprinkle capsules 5mg and 10mg is also awaiting FDA approval.
Aciphex delayed-release sprinkle capsules are indicated for curing Gastroesophageal Reflux Disease (GERD), maintenance of healing of GERD and improvement of GERD symptoms in children 1 to 11 years of age.
Source:
http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda-grants-additional-marketing-exclusivity-for-eisais-gerd-drug-121212
