FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: INTERCEPT PHARMACEUTICALS, INC., ET AL.; WITHDRAWAL OF APPROVAL OF NEW DRUG APPLICATION FOR OCALIVA (OBETICHOLIC ACID) TABLETS, 5 MILLIGRAMS AND 10 MILLIGRAMS, AND THREE ABBREVIATED NEW DRUG APPLICATIONS FOR OBETICHOLIC ACID TABLETS, 5 MILLIGRAMS AND 10 MILLIGRAMS

WASHINGTON, Nov. 24 -- Food and Drug Administration has issued a notice called: Intercept Pharmaceuticals, Inc, et al.; Withdrawal of Approval of New Drug Application for OCALIVA (Obeticholic Acid) Tablets, 5 Milligrams and 10 Milligrams, and Three Abbreviated New Drug Applications for Obeticholic Acid Tablets, 5 Milligrams and 10 Milligrams.

The notice was published in the Federal Register on Nov. 24 by Lowell M. Zeta, Acting Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is withdrawing approval of the new drug application (NDA) for OCALIVA (obeticholic acid) tablets, 5 milligrams (mg) and 10 mg, held by Intercept Pharmaceuticals, Inc, 305 Madison Ave, Morristown, N...