Pink Sheet

Competitive Generic Therapy Designations Growing Despite Lack Of Guidance

27 Jun 2018

US FDA developing document describing program operations, but that has not stopped sponsors from requesting and receiving the breakthrough-like designation.

BOSTON -- The US FDA's Office of Generic Drugs is designating ANDAs as competitive generic therapies, making them available for additional exclusivity upon approval, even though program operations and expectations remain largely a mystery for sponsors.

Maryll Toufanian, acting director of the OGD Office of Generic Drug Policy, told the Pink Sheet in a June 26...