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The Food and Drug Administration (FDA) has decided that the drug NYMALIZE (nimodipine), oral solution at a strength of 3 mg/mL, was not taken off the market for safety or effectiveness reasons. This decision enables the approval of generic versions of this drug, provided they meet other requirements. Although the 3 mg/mL version was discontinued, the FDA believes it would still be safe and effective if sold today, but suggests making some labeling changes to prevent confusion with another version that is 6 mg/mL.

The Food and Drug Administration (FDA) announced the determination of the regulatory review period for the drug SOHONOS, which is used to treat fibrodysplasia ossificans progressiva in certain children and adults. This determination is related to a patent extension application made to the U.S. Patent and Trademark Office (USPTO). FDA found that the drug underwent a lengthy review process, including 6,657 days of testing and 869 days of approval proceedings. People who believe any of the review dates are incorrect can submit comments to FDA, and petitioners can also request a review of the applicant's diligence during this period.

The Food and Drug Administration (FDA), part of the Department of Health and Human Services, has issued a priority review voucher to Novo Nordisk, Inc. for their drug ALHEMO (concizumab-mtci), which is used to reduce bleeding episodes in patients with certain types of hemophilia. This award is part of the FDA's program to encourage the development of treatments for rare pediatric diseases. The voucher is given because ALHEMO met specific criteria for applications targeting rare pediatric conditions.

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Pharmaceutical, Inc. However, because Breckenridge Pharmaceutical requested to keep their approval before it was withdrawn, the FDA has corrected this, and the approval of ANDA 209325 remains in effect.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) has announced a decision to deny Vanda Pharmaceuticals a hearing regarding their supplemental new drug application for HETLIOZ, which is intended to treat insomnia by aiding in sleep initiation. The FDA concluded that the application did not provide sufficient evidence to prove the drug's effectiveness and safety for this new use. Previously, on March 4, 2024, the Center for Drug Evaluation and Research (CDER) issued a complete response letter indicating Vanda's application could not be approved as is. After reviewing submissions from both parties, the FDA finalized their decision not to approve the new indication for the drug on February 28, 2025.

The Food and Drug Administration (FDA) announced that certain drug products, including Bentyl Preservative Free (Dicyclomine Hydrochloride) Injection, 10 Milligrams/Milliliters, have not been taken off the market for safety or effectiveness issues. This means that generic versions of these drugs can still be approved by the FDA and sold, as long as they follow the necessary legal and regulatory guidelines. The drugs will be listed in the "Discontinued Drug Product List" in the Orange Book because they are no longer being sold, but not for reasons related to safety or effectiveness.

The Food and Drug Administration (FDA) is proposing to reject the new drug application from Vanda Pharmaceuticals for TRADIPITANT capsules, intended to treat nausea in gastroparesis. The application was found lacking as it did not provide substantial evidence of the drug’s effectiveness and safety based on submitted studies and data. Vanda has the option to request a hearing to contest this decision, though they must address all the identified deficiencies. If no hearing request is filed, or if it is not deemed substantial, the FDA will officially deny the application.

The Food and Drug Administration (FDA) announced a correction to a previous notice regarding the withdrawal of approval for 23 abbreviated new drug applications (ANDAs). These applications, held by companies like Fosun Pharma USA Inc., Baxter Healthcare Corp., Celltrion USA, and i3 Pharmaceuticals, were initially set to be withdrawn by August 28, 2024. However, because these companies asked in time not to have their ANDAs withdrawn, the approvals remain valid. This notice clarifies the error and ensures the continued approval of these drug applications.

The Food and Drug Administration (FDA) has announced that they approved the use of ALYFTREK, a drug made up of vanzacaftor, tezacaftor, and deutivacaftor, on December 20, 2024. This approval includes the use of a priority review voucher, which is a special designation given to sponsors of drugs for rare pediatric diseases. These vouchers are part of a program designed to encourage the development of treatments for rare conditions found in children. For more information, individuals can visit the FDA's official website linked in the document.

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.