Sepracor's Estorra Is "Approvable"; Launch Goal Is Mid-Year
This article was originally published in The Pink Sheet Daily
Executive Summary
Sepracor will resubmit its NDA for the insomnia agent in one to three months after receiving an "approvable" letter Feb. 27.
You may also be interested in...
Sepracor Resubmits Estorra NDA; Expected Approval Pushed To Year-End
The company expects FDA will take six months to review the eszopiclone resubmission. Sepracor had earlier expressed optimism about a two-month review, which would have set an approval target for the sleep agent around mid-year.
Sepracor Resubmits Estorra NDA; Expected Approval Pushed To Year-End
The company expects FDA will take six months to review the eszopiclone resubmission. Sepracor had earlier expressed optimism about a two-month review, which would have set an approval target for the sleep agent around mid-year.
Sepracor, MedPointe To End Astelin Co-Promotion Agreement
The companies will continue to detail the product until June 30, then Sepracor will be responsible for sample coverage until the end of the year. Sepracor plans to focus sales efforts on in-house products.