Marksans Pharma Limited has announced receiving final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Loratadine Tablets USP 10 mg. This over-the-counter (OTC) medication is a generic version of Bayer Healthcare’s Claritin tablet in the same strength.
Loratadine, an antihistamine, is indicated for the treatment of allergic rhinitis caused by pollen and upper respiratory tract allergies. It effectively alleviates symptoms such as itching, runny nose, watery eyes, and sneezing associated with “hay fever” and other allergies.
The USFDA approval marks a significant milestone for Marksans Pharma, enhancing its portfolio in the OTC segment and reaffirming its commitment to providing high-quality generic medications.
