|
|
|
Company Name
|
Ironwood Pharmaceuticals, Inc.
|
|
Drug Name
|
Linaclotide (NDA)
|
|
Event Name
|
FDA decision on Linaclotide for treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation
|
|
Event Date
|
09/09/2012
|
|
Outcome
|
FDA approved Linaclotide to treat irritable bowel syndrome with constipation, on August 30.
|
|
Drug Status
|
The NDA for Linaclotide was submitted to FDA on Aug9, 2011. With a standard 10-month review timeline, the target action date was expected to occur in June 2012. But in April of this year, the FDA extended the review period to September, 2012
|
|
Rival Drugs
|
|
|
Market Potential
|
|
|
Other Approvals
|
|
|
News |
|
|
|
Return to FDA Calendar
|