Search Results for citation:"90 FR 12163"

The Food and Drug Administration (FDA) is withdrawing approval for four abbreviated new drug applications (ANDAs) because the manufacturers informed the FDA that these drugs are no longer being sold. The manufacturers requested this action and have given up their right to a hearing. As of April 14, 2025, these drugs cannot legally be sold or introduced into interstate commerce in the U.S. unless they have an approved application. However, any remaining stock of these drugs can be used until they expire or are sold out.

The Food and Drug Administration (FDA) is removing its approval for eight different abbreviated new drug applications (ANDAs), as the companies that made these drugs informed the FDA that the drugs are no longer being sold. The companies asked the FDA to cancel these approvals, and the FDA has agreed to do so as of April 14, 2025. Even though approval is being withdrawn, the decision does not prevent the companies from filing new applications in the future if desired. Also, any existing drugs from the list that are still in stock after this date can be sold until they run out, expire, or otherwise become unsuitable.