New User:

Forgot your password?

Stock Market & Financial Investment News

News Breaks
March 25, 2013
06:57 EDTVNDAVanda reports successful completion of pre-NDA meeting with FDA on tasimelteon
Vanda Pharmaceuticals announced that the company held a pre-NDA meeting with the Division of Neurology Products of the FDA to discuss the regulatory path for filing a New Drug Application, or NDA, for tasimelteon, a circadian regulator, for the treatment of Non-24-Hour Disorder. Non-24 is a serious, rare circadian rhythm disorder that affects a majority of totally blind individuals. Currently there is no FDA approved treatment for Non-24. At the pre-NDA meeting, the FDA confirmed that the efficacy and safety data proposed by Vanda to be submitted in the tasimelteon NDA for Non-24 is adequate to support filing. The NDA supporting package that includes data from clinical pharmacology, pre-clinical pharmacology program, chemistry and manufacturing was also deemed adequate to support filing.
News For VNDA From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
September 23, 2015
16:31 EDTVNDAVanda announces listing of new Fanapt patent in FDA Orange Book
Vanda Pharmaceuticals announced that a Fanapt patent, number 9,138,432 ('432 patent), is now listed in the U.S. FDA publication Approved Drug Products With Therapeutic Equivalence Evaluations, commonly known as the Orange Book. As described in the Orange Book, this patent covers a method of treating schizophrenia by administering Fanapt to a patient by reducing the dose in patients who are also being treated with the antidepressant fluoxetine. The '432 patent was issued by the United States Patent and Trademark Office in September 2015 and expires in September 2025. Prior to this newly listed patent, the Fanapt Orange Book listed patents were the U.S. composition of matter '198 patent, the '610 patent, the '776 patent, the '638 patent, the '742 patent, the '254 patent, the '255 patent, and the '256 patent expected to expire in November 2016, November 2027, August 2030, October 2030, January 2031, December 2031, December 2030, and February 2031 respectively.

Sign up for a free trial to see the rest of the stories you've been missing.
I agree to the disclaimer & terms of use