Cycle Pharmaceuticals has received approval from the 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 five 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.
“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 U.S. market,” said Antonio Benedetti, CEO, Cycle.
(Source: Cycle Pharmaceuticals Ltd)