Search Results for keywords:"abbreviated new drug applications"

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 Even though approval is being withdrawn, the decision does not prevent the companies from filing new applications in the future if desired.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.

The Food and Drug Administration (FDA) issued a correction notice regarding the withdrawal of approval for 23 abbreviated new drug applications (ANDAs), which was published in the Federal Register on January 15, 2025. Initially, it was stated that FDA was withdrawing the approval of ANDA 209325 for miglustat capsules held by Breckenridge Pharmaceutical, Inc. However, because Breckenridge Pharmaceutical requested to keep their approval before it was withdrawn, the FDA has corrected this, and the approval of ANDA 209325 remains in effect.

The Food and Drug Administration (FDA) is withdrawing approval for two abbreviated new drug applications (ANDAs) from Flamingo Pharmaceuticals Ltd. This decision is because the company has consistently failed to submit the necessary annual reports for these drug applications. Despite being given a chance for a hearing, the company did not respond, resulting in a waiver of their hearing opportunity and any claims about the drug's legal status. Therefore, the approval for these drugs will officially be withdrawn on December 31, 2024.

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) has decided to withdraw its approval of 23 abbreviated new drug applications (ANDAs) after being informed by the applicants that these drug products are no longer being marketed. This withdrawal is effective from February 14, 2025. The applicants have waived their right to a hearing regarding this decision. According to the regulations, any remaining inventory of these products can be dispensed until it runs out, expires, or otherwise becomes non-compliant.

The Food and Drug Administration (FDA) is withdrawing the approval of 27 abbreviated new drug applications because the companies that made these drugs told the FDA that they are no longer selling them. The withdrawal means these drugs will no longer have permission to be sold in the market. This action will take effect on February 16, 2021, but any remaining drug inventory that is still compliant with regulations can be used up until it runs out or expires.