Vanda Sues US FDA For Documents Backing Complete Response For Hetlioz Jet Lag Indication
FOIA exemption does not apply to medical and statistical reviews of its sNDA, company claims. It says it needs the information to adapt its development program and determine if the agency made an error.
You may also be interested in...
Absence Of Braille In Generic Hetlioz Label Merits Its Withdrawal, Vanda Lawsuit Argues
Vanda complaint against US FDA says generic label is not the same as Hetlioz and omission of braille lettering will increase medication errors. Company seeks recall of Teva’s product.
Vanda May Go Another Round With US FDA Over Hetlioz Jet Lag Indication
Agency offers Vanda chance to request a hearing over its plan to refuse to approve its supplemental new drug application. Such a hearing seems unlikely given FDA’s rejection of past requests and Vanda’s track record with the agency.
US FDA’s Fast Track Designation Policy Faces Unusual Legal Challenge
Vanda Pharmaceuticals contends the agency unfairly denied its request for fast track designation for tradipitant. This appears to be the first time the FDA has been sued over a denial. In FY 2021, CDER denied 78 requests for the designation and granted 173.