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Endo Gets Surprise Aveed Approval, But REMS Could Be A Roadblock

 
• By Lisa LaMotta

After seven years of rejection, Endo finally gets FDA’s go-ahead on its long-acting testosterone treatment, but a strict REMS program and plenty of market competitors will make the drug’s launch difficult.

Despite mounting safety concerns, FDA has finally given the green light to Endo Pharmaceuticals Inc.’s long-acting injectable low testosterone treatment Aveed after three previous complete responses. While the approval is a win for the company, the Risk Evaluation and Mitigation Strategy that came with it will make the marketing of the drug more complicated in an already saturated market.

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More from United States

New Medicare Negotiation Program ‘Iterations’ Inevitable, Former CMS Official Blum Says

 
• By Cathy Kelly

Jonathan Blum, who was principal deputy administrator during the Biden Administration, explained the agency’s approach to setting up the price negotiation program and said changes likely will be implemented by the Trump Administration.

US FDA Rare Disease Innovation Hub’s Goals Align With Trump, Leader Says

 
• By Sue Sutter

The hub’s goals of efficiency, centralization and coordination fit with the Trump Administration’s current focus for the FDA, Amy Comstock Rick, director of strategic coalitions, told the Biopharma Congress.

Pharma Still Nervous While Riding Trump’s Tariff Rollercoaster

 
• By Jessica Merrill

The rollout of Trump’s plan has been a policy whiplash, but despite a 90-day pause on tariffs, the US president still appears to be holding a grudge with industry over drug pricing.

US FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 
• By Urtė Fultinavičiūtė

The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.

More from North America

US Pharma Tariff Reprieve May Be Ending

 
• By Jessica Merrill

Sector-specific tariffs, including on pharmaceuticals, could be announced as early as this week.

Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 
• By Derrick Gingery

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

Trump’s US FDA Takeover Similar To Flat Earth Proponents Running NASA, Woodcock Says

 
• By Sue Sutter

The former principal deputy commissioner said the “decapitation” of senior leadership will make resolving internal disputes more difficult, which will slow application reviews. Woodcock also called the FDA layoffs a slow-moving catastrophe.