Marksans Pharma Secures USFDA Nod for Loratadine

Marksans Pharma Ltd has gained final USFDA approval for its generic Loratadine tablets, used to treat allergic rhinitis. This approval allows the company to market a generic version of Clartin, matching Bayer Healthcare's product strength. Loratadine is an antihistamine for allergies.

Marksans Pharma Ltd announced on Friday it has received the green light from the US Food and Drug Administration (USFDA) to market its generic Loratadine tablets. The approval pertains to the treatment of allergic rhinitis, a common condition caused by allergies.

This regulatory approval applies to the company's abbreviated new drug application (ANDA) for its Loratadine tablets, each with a strength of 10 mg. This product is a generic version of Clartin, which matches the strength of Bayer Healthcare's well-known allergy medication.

Loratadine is recognized as an effective antihistamine, tackling symptoms including itching, a runny nose, watery eyes, and sneezing, often associated with hay fever and other allergies. The product targets the over-the-counter (OTC) market, providing an affordable alternative for allergy sufferers.

(With inputs from agencies.)