FDA Clears BIAXIN XL Oral Tablets for Sale, Citing Lack of Safety or Effectiveness Concerns

Summary

The Food and Drug Administration (FDA) has determined that BIAXIN XL Oral Tablets were not withdrawn from sale due to safety or effectiveness concerns. This decision means the FDA will not initiate withdrawal procedures for abbreviated new drug applications (ANDAs) referencing these products, and will continue to approve new applications as long as they meet regulatory requirements.