![](http://investorshub.advfn.com/images/default_ih_profile2_4848.jpg?cb=0)
Friday, July 15, 2016 7:30:20 PM
The FDA usually takes close to the full 60 days to accept/reject the NDA.
As an example, Relypsa recently went through an NDA for Veltassa:
- October 22, 2014: Submitted NDA
- December 15, 2014: NDA accepted by the FDA
- January 5, 2015: ("day-74 letter") Assigned a PDUFA date of October 21, 2015 and FDA "further indicated that it does not currently plan to convene an Advisory Committee for advice on the company's NDA.". This was a standard 10-month review.
- October 21, 2015: FDA approves Veltassa
Recent IPCI News
- Suspension de la négociation par l'Organisme canadien de réglementation des investissements - IPCI • PR Newswire (Canada) • 03/06/2024 12:55:00 PM
- Canadian Investment Regulatory Organization Trading Halt - IPCI • PR Newswire (Canada) • 03/06/2024 12:51:00 PM
FEATURED Mawson Finland Provides Update on Exploration Activities at Rajapalot • Aug 21, 2024 9:06 AM
Unitronix Announces Strategic Entry into Cryptocurrency Space • UTRX • Aug 21, 2024 10:00 AM
Avant Technologies to Implement Robust Cybersecurity Measures for AI-Driven Healthcare Solutions • AVAI • Aug 21, 2024 8:00 AM
HealthLynked Corp. Announces Second Quarter and First Half 2024 Results: Continued Cost Reductions Set the Stage for Strategic Shift to App-Based Technology Services • HLYK • Aug 16, 2024 8:00 AM
PickleJar Announces Official Name Change and New Ticker Symbol • NREG • Aug 15, 2024 2:23 PM
VAYK's Q2 Profit Added to Accumulated Net Profit of Over $2.2 Million In 18 Months • VAYK • Aug 15, 2024 9:07 AM