Cycle Pharmaceuticals’ Ketorolac Tromethamine Injection receives FDA approval

Cycle Pharmaceuticals Ltd (Cycle) has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Ketorolac Tromethamine Injection 30mg/mL. The Ketorolac Tromethamine Injection is a nonsteroidal anti-inflammatory drug (NSAID) and is indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level.

The Ketorolac Tromethamine Injection has been developed in collaboration with Caplin Point Laboratories Ltd (Caplin Point) and is manufactured at their FDA approved site.

"After the successful launch of Nityr™ (nitisinone) tablets last month from our Orphan Drugs Division, we are proud to be announcing the first product from our Generics Division." said Steve Fuller, Head of Business Development, Cycle Pharmaceuticals.

Cycle has selected Virtus Pharmaceuticals, LLC (Virtus) as the importer and distributor of Ketorolac Tromethamine Injection in the U.S.

"We are proud to have partnered with Caplin Point, their injectable drug product development and manufacturing capabilities are impressive, and their support has been key to meet this approval timeline. This FDA approval is the first of Cycle’s promising pipeline of generic drugs, which will alleviate unmet demand from patients and keep prices fair." said Antonio Benedetti, CEO of Cycle Pharmaceuticals.