Department of Health and Human Services August 10, 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that the U.S. Pharmacopeial Convention has filed a petition proposing that the food additive regulations that incorporate by reference food-grade specifications from prior editions of the Food Chemicals Codex (FCC) be amended to incorporate by reference food-grade specifications from the FCC, 7th Edition.

The Food and Drug Administration (FDA) is announcing its determination that DECA-DURABOLIN (nandrolone decanoate) Injection, 200 milligrams/milliliter (mg/mL), 1 mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for nandrolone decanoate, 200 mg/mL, 1 mL, if all other legal and regulatory requirements are met.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive license to practice the inventions embodied in:

The Food and Drug Administration (FDA) has determined that the five drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.