Market Overview

Endo Pharma Says FDA Issues CRL on Aveed NDA, Says Didn't Include Request for Added Trials

Share:
Related ENDP
Top Takeaways From BMO's Specialty Pharma Day
US Stock Futures Slip; All Eyes On Jobs Report
Egalet Reports Encouraging Results on Pain Drug Egalet-002 - Analyst Blog (Zacks)

Endo Pharmaceuticals Inc., a subsidiary of Endo Health Solutions Inc. (Nasdaq: ENDP) announced today that the U.S. Food and Drug Administration (FDA)  has issued a complete response letter regarding the New Drug Application (NDA) for Endo's long-acting testosterone undecanoate injection, AVEED™, for men diagnosed with hypogonadism.

The complete response letter did not include requests for the company to perform additional clinical studies.  The FDA outlined the steps necessary to support approval of the NDA and updated the requirement for a Risk Evaluation and Mitigation Strategy (REMS).  Specifically, the FDA has requested that the REMS include a Medication Guide as well as Elements to Assure Safe Use (ETASU) to mitigate the risks and severe complications related to post-injection reactions. 

Posted-In: News FDA

 

Related Articles (ENDP)

Around the Web, We're Loving...

Get Benzinga's Newsletters