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STAT+: Novo asks FDA to bar compounders from making Ozempic copies

STAT

Novo Nordisk has asked the Food and Drug Administration to bar compounding pharmacies from making copies of its blockbuster weight loss drug semaglutide, arguing that the medication is too complex for the pharmacies to safely make. The FDA still has to make a decision on whether to officially place semaglutide on the lists.

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STAT+: Pharmalittle: We’re reading about FDA guidance on AI, meds releasing ‘forever chemicals,’ and more

STAT

The brief, 20-page document, instead, focuses on AI models used to produce data that supports regulatory decision-making about the safety, effectiveness, or quality of drugs.   Most of the compounds came from commonly prescribed medications including antidepressants and statins. Continue to STAT+ to read the full story…

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STAT+: Pharmalittle: We’re reading about Novo targeting compounded obesity drugs, an Amgen ‘at risk’ launch, and more

STAT

Food and Drug Administration to bar compounding pharmacies from making copies of its blockbuster weight loss drug semaglutide, arguing that the medication is too complex for the pharmacies to safely make , STAT reports. The FDA still has to make a decision on whether to officially place semaglutide on the lists.

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How much does semaglutide cost per month?

The Checkup by Singlecare

The medication is available in both brand-name and compounded forms, although the compounded forms are not FDA approved. Compounded semaglutide is made by special compounding pharmacies rather than pharmaceutical companies. Does insurance cover compounded semaglutide? Does insurance cover Ozempic?

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FDA guidance highlights E&L considerations for ophthalmic drug products

European Pharmaceutical Review

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. This document is revised from a version published in October 2023.

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STAT+: Pharmalittle: We’re reading about a Zepbound-Wegovy faceoff, compounders slamming Novo, and more

STAT

But documenting the differences between Zepbound and Wegovy in a rigorous way might allow Lilly to make marketing claims about Zepbound’s superior efficacy.   A trade group for compounding pharmacies slammed an attempt by Novo Nordisk to convince the U.S. That, in turn, could help the company gain market share against Novo. 

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Revised Final Guidance on Nitrosamines Offers New Recommendations for Assessment and Control

The FDA Law Blog

Claud — Last week, FDA revised one of its two guidances relating to nitrosamines, Control of Nitrosamine Impurities in Human Drugs. FDA starts by setting the limit of what it views as acceptable intake (AI) limits, so that manufacturers and applicants can know what targets they should hit. By John W.M.

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