Elite Pharmaceuticals, Inc. (ELI) Holds Clinical Guidance Meeting With The FDA On Its Abuse Deterrent Pain Program
10/27/2006 11:06:03 AM
NORTHVALE, N.J.--(BUSINESS WIRE)--Elite Pharmaceuticals, Inc. (AMEX: ELI) met with the U.S. Food and Drug Administration (FDA) for a Type C clinical guidance meeting regarding ELI-216, the Company’s abuse deterrent oxycodone hydrochloride product. The purpose of the meeting was to review the complete abuse deterrent clinical program. The FDA provided guidance and comments on the New Drug Application (NDA) 505(b)2 program proposed by the Company that are helpful in understanding the steps needed to complete the entire developmental program for this product. As a result of meeting with the FDA, the Company expects to continue with the development program and timetable outlined as previously disclosed.
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