In the August 27, 2015, Federal Register, FDA published its determination that Biaxin XL were not withdrawn from sale for reasons of safety or effectiveness. FDA will not begin procedures to withdraw approval of abbreviated new drug applications ("ANDAs") that refer to these products and will continue to evaluate and approve ANDAs that refer to the products if they meet all other regulatory requirements.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
