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.
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