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Clarus' Jatenzo Suffers From Off-Label Concerns At US Advisory Committee

 
• By Derrick Gingery

Oral testosterone candidate loses close vote as many panelists worry that convenience could spur misuse; REMS could offer reassurance.

FDA Advisory Committee Feature image

Concerns about off-label use drove most of the votes against approval during the the US FDA's Bone, Reproductive and Urologic Drugs Advisory Committee's review of Clarus Therapeutics Inc.'s oral testosterone candidate Jatenzo (testosterone undecanoate) on Jan. 9

Many panel members were sympathetic to the need for an oral therapy for those who would fit the indication, which...

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More from US FDA Performance Tracker

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 
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The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US

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Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
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Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

More from Regulatory Trackers

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
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Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

EU Authorization Before US? Biologics Manufacturing Is Likely To Blame

 
• By Bridget Silverman

In the infrequent cases when EU authorization precedes US FDA approvals of new products, biologics manufacturing issues are usually to blame, a Pink Sheet analysis found.