Daily Rules, Proposed Rules, and Notices of the Federal Government
The drug products listed in table 1 in this document are no longer marketed, and Ranbaxy has requested that FDA withdraw approval of the applications. The company has also waived its opportunity for a hearing. Ranbaxy requested withdrawal of approval under a Consent Decree of Permanent Injunction (Decree) entered in
Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(e)) and under authority delegated to the Director, Center for Drug Evaluation and Research, by the Commissioner, approval of the applications listed in table 1 in this document, and all amendments and supplements thereto, is hereby withdrawn, effective September 21, 2012. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the FD&C Act (21 U.S.C. 331(a) and (d)).