New River's application for ADHD drug accepted for FDA review

By Lisa Kerner

Erie, Pa., Jan. 27 - New River Pharmaceuticals Inc. said the Food and Drug Administration accepted the company's New Drug Application for NRP104 for review.

New River submitted the application seeking approval to manufacture and market the investigational compound for the treatment of attention deficit hyperactivity disorder (ADHD) in pediatric populations ages 6 to 12, according to a company news release.

The company said it is developing and commercializing NRP104 in collaboration with Shire plc.

New River expects the drug candidate to be approved and launched by the end of this year, officials said.

Radford, Va.-based New River Pharmaceuticals is a specialty pharmaceutical company.

Shire is a specialty pharmaceutical company based in Basingstoke, England.

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