Search Results for keywords:"safety and effectiveness"

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) has determined that DECADRON, a medication with the active ingredient dexamethasone sodium phosphate, was not taken off the market for reasons related to safety or effectiveness. This decision allows continued approval of generic versions of the drug as long as they comply with necessary legal and regulatory standards. DECADRON will remain on the "Discontinued Drug Product List," which includes drugs discontinued for reasons other than safety or effectiveness. The FDA reviewed data and found no evidence of safety concerns leading to the drug's withdrawal.

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) has determined that the drug VIBRAMYCIN (doxycycline) for oral suspension was not taken off the market due to safety or effectiveness concerns. This decision allows the FDA to continue approving generic versions of this medication as long as they meet legal and regulatory criteria. VIBRAMYCIN is included in the “Discontinued Drug Product List” because it was removed from sale for reasons unrelated to safety or effectiveness. If necessary, the FDA may require updates to the drug’s labeling to align with current standards.

The Food and Drug Administration (FDA) is asking for public comments on its data collection efforts related to the Biosimilars User Fee Program, which supports the development of biosimilar drugs. The program, part of the Biologics Price Competition and Innovation Act, helps guide the approval process for biosimilars by allowing companies to pay user fees to the FDA. These fees are collected to ensure the safe and effective development of these drugs. Companies interested in participating should submit comments by March 5, 2025, and can find more information on the FDA's website.

The Food and Drug Administration (FDA) has announced the availability of draft guidance for devices that use artificial intelligence (AI)-enabled software functions. This draft guidance, once finalized, will give recommendations for what should be included in marketing submissions, focusing on safety and effectiveness. It suggests a total product lifecycle (TPLC) approach, which considers the design, development, and implementation stages of AI-enabled devices. Public comments on this draft are sought to ensure that FDA’s guidance aligns with the fast-evolving field of AI and adequately addresses performance and risk concerns.

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 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.