Cycle Pharma Receives FDA Approval And Launches Ketorolac Tromethamine Injection 30mg/ml In The U.S.

CAMBRIDGE, England--(BUSINESS WIRE)--Cycle Pharmaceuticals Ltd (“Cycle”) is pleased to announce that it 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. 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.

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.

For full prescribing information, including Boxed Warning, please visit www.cyclepharma.com/ketorolac

About Cycle Pharmaceuticals Ltd.

Cycle is a pharmaceutical company that optimizes and increases access to existing pharmaceuticals. Specifically, Cycle focuses on three areas of pharmaceutical development:

- Improving orphan drugs, which treat the under-served rare disease patient community;

- Reinstating generic drug products that have been previously marketed; and

- Working with our academic and other partners to extend pharmaceuticals to new medical areas where there is clear unmet need. The company’s global headquarters is in Cambridge, England. For further information, please visit www.cyclepharma.com.

About Caplin Point Laboratories Ltd.

Caplin Point (NSE: CAPLIPOINT) manufactures and markets pharmaceutical products such as lyophilized, biotech as well as a full range of generic products. The company’s vision is to create new niches in existing markets. Caplin Point envisages implementing their unique business model across the globe to ensure access to quality medicines at affordable prices. The company’s headquarters is in Chennai, India. For further information, please visit: www.caplinpoint.net

About Virtus Pharmaceuticals, LLC

Virtus’ mission is to be the leading specialty niche pharmaceutical company providing the highest quality products through experienced leadership, innovative approaches and outstanding customer service. For more information, please visit www.virtusrx.com