In Brief: Miles' Nisocor

Executive Summary

Miles' Nisocor: Firm considering outlicensing the calcium channel blocker extended-release nisoldipine, which was approved Feb. 2. Miles says it is "reviewing various commercial options in addition to directly marketing Nisocor," including copromotion and out-licensing. Nisocor was given a "1S" rating by FDA, designating a new molecular entity receiving a standard review. The NDA (20-356) for Nisocor was originally submitted on March 31, 1993. Miles resubmitted the application on Aug. 3, 1994 after receiving a "not approvable" letter from FDA in March 1994. Reasons for rejecting the initial application cited by the agency included inadequate stability data to establish shelf-life of the product and the lack of a stereochemical identity test to demonstrate that the drug is a racemic mixture. Nisocor was approved in tablet strengths of 10 mg, 20 mg, 30 mg and 40 mg...