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

摘要

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, NJ 07960 (Intercept). In addition, FDA is withdrawing approval of three abbreviated new drug applications (ANDAs) for obeticholic acid tablets, 5 mg and 10 mg, from three separate ANDA holders. Intercept voluntarily requested withdrawal of its NDA, and Apotex, Inc., Lupin Limited, and MSN Laboratories Private Limited voluntarily requested withdrawal of their respective ANDAs, under Sec. 314.150(d) (21 CFR 314.150(d)). The expedited withdrawal procedures set forth in section 506(c)(3)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) have been waived.