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Leveraging Online FDA Information to Accelerate ANDA Timelines

thought leadership

Delays in Abbreviated New Drug Application (ANDA) submissions or setbacks during FDA review can mean missed market opportunities, especially in competitive therapeutic areas.

FDA 52
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FDA Approves Merck’s ENFLONSIA™ to Prevent RSV in Infants

The Pharma Data

FDA Approves Merck’s ENFLONSIA™ to Protect Infants from Severe RSV Illness Merck operating as MSD outside the United States and Canada, has received a significant regulatory milestone with the U.S. Food and Drug Administration (FDA) granting approval for ENFLONSIA™ (clesrovimab-cfor).

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To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

FDA Law Blog: Biosimilars

Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. Koblitz & Kurt R. Similar requirements would apply to BLA sponsors.

FDA 105
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Fitusiran

New Drug Approvals

2] Fitusiran was approved for medical use in the United States in March 2025. [2] 2] The fixed dose of fitusiran is not approved because it led to excessive clotting in some participants. [2] 2] The US Food and Drug Administration (FDA) granted the application for fitusiran orphan drug and fast track designations. 26 March 2025.

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How to Ensure Patient Safety with Generic Drugs

Drug Patent Watch

This means ensuring that generic manufacturers adhere to the same quality control standards as brand-name companies, and that patients have access to accurate and reliable information about the medications they're taking. So, what can we do to ensure patient safety with generic drugs? Share your thoughts and experiences in the comments below.

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FDA Approves Updated ADUHELM™ Prescribing Information to Emphasize Population Studied in Clinical Trials

The Pharma Data

The update clarifies the indication by emphasizing information about the disease stages studied in the ADUHELM clinical trials. Information about the population studied has been previously communicated by Biogen and Eisai, including in the companies’ statement of June 23, 2021. Please see the full Prescribing Information.

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Metabolism of 2023 FDA Approved Small Molecules – PART 2

Metabolite Tales Blog

link] [4] FDA prescribing information for INPEFA TM (sotagliflozin). link] [6] FDA prescribing information for FABHALTA® (iptacopan). link] [6] FDA prescribing information for FABHALTA® (iptacopan). link] [7] FDA prescribing information for LITFULOTM TM (ritlecitinib). Drug Metab Dispos.