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 Tablets 10mg. Ketorolac Tromethamine Tablets, a nonsteroidal anti-inflammatory drug (“NSAID”), are indicated for the short-term (up to 5 days in adults), management of moderately severe acute pain that requires analgesia at the opioid level and only as continuation treatment following intravenous (“IV”) or intramuscular (“IM”) dosing of ketorolac tromethamine, if necessary.
“After the successful launch of Ketorolac Tromethamine IV last year, we are proud to be announcing the second product approval from our Generics Division” said Brian Sergenian, North America Director, Cycle.
“We are pleased to be expanding consistently our portfolio in line with our launch targets. With this approval we continue the expansion of our business with a special focus on the US market” said Antonio Benedetti, CEO, Cycle.
For full prescribing information, including Boxed Warning, please visit www.cyclepharma.com/ketorolac-tablets
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.
