Caplin Point Laboratories’ arm gets USFDA approval for Ketorolac tromethamine Ophthalmic Solution

28 Mar 2024 Evaluate

Caplin Point Laboratories’ subsidiary -- Caplin Steriles 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% 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 IQVIATM (IMS Health), Ketorolac tromethamine Ophthalmic Solution 0.5% had US sales of around $36 million for the 12-month period ending December 2023.

Caplin Point Laboratories is engaged mainly in manufacturing a wide range of Ointments, Creams and other External application preparations in addition to the regular segments of pharmaceutical formulations.


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