Athenex Sues FDA To Get Vasopressin On List Of Drugs That Can Be Compounded

 
• By Brenda Sandburg
  
Generate a summary of this article
Listen to this article
Beta

Company argues there is a clinical need for its ready-to-use, preservative-free compounded formulation of vasopressin but agency says Vasostrict is available in a dose without the preservative.

Side view of titration in a compounding pharmacy

The US FDA is facing a challenge its its restrictions on compounding a drug – but interestingly, Athenex Inc. is not using the now-familiar pricing argument in making its case that its product should be available as an alternative to the brand. The company contends that FDA wrongly excluded vasopressin from the list of bulk drug substances that can be used in compounding because of an already approved product, Par Pharmaceutical's Vasostrict.

Athenex filed suit against FDA on March 4, the day the agency issued a Federal Register notice that it...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

SpotifyApple PodcastsWebsite

More from US FDA

PS-AgencyLeadership (Premium-1): Study Reveals How Immune System of Astronauts Breaks Down

Recent studies show that spaceflight can significantly weaken astronauts’ immune systems, making them more susceptible to infections and health complications during and after missions. Understanding these changes is crucial for ensuring the safety of future long-duration space travelers.

Nancy Test Circulable Section Geography

 
• By Brian Bossetta

This is a short description

New US FDA Adcomm Trend: Approved Cancer Meds Get Another Look When Competitors Coming

 
• By Sarah Karlin-Smith

Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.

Califf: Not Wise To Create Problems Related to Chinese Pharma Supply Chain Dependence

 
• By Sarah Karlin-Smith

The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.

More from Agency Leadership

New US FDA Adcomm Trend: Approved Cancer Meds Get Another Look When Competitors Coming

 
• By Sarah Karlin-Smith

Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.

Califf: Not Wise To Create Problems Related to Chinese Pharma Supply Chain Dependence

 
• By Sarah Karlin-Smith

The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.