Caplin Steriles gets USFDA approval for Ketorolac Tromethamine Ophthalmic Solution

Caplin Steriles, a subsidiary company of Caplin Point Laboratories has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ketorolac tromethamine Ophthalmic Solution 0.5% (eye drops), a generic therapeutic equivalent version of (RLD), ACULAR Ophthalmic Solution of Allergan Inc.

Ketorolac tromethamine Ophthalmic Solution 0.5 per cent is a nonsteroidal, anti-inflammatory indicated for the treatment of inflammation following cataract surgery and for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. According to IQVIA (IMS Health), Ketorolac tromethamine Ophthalmic Solution 0.5 per cent had US sales of approximately $36 million for the 12-month period ending December 2023.