Caplin Point Laboratories (Caplin Point) is pleased to inform that Cycle Pharmaceuticals (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.
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 at Caplin Point and will be manufactured at Caplin's FDA approved site. Cycle has selected Virtus Pharmaceuticals, LLC ("Virtue) as the importer and distributor of Ketorolac Tromethamine Injection in the U.S.
Shares of the company gained Rs 1.3, or 0.18%, to trade at Rs 728.25. The total volume of shares traded was 15,762 at the BSE (10.46 a.m., Wednesday).