Marksans Pharma receives USFDA approval for its generic version of Loratadine tablets, a treatment for allergic rhinitis. The approval marks a significant milestone for the company.
Photograph: Yves Herman/Reuters
New Delhi, Nov 22 (PTI) Marksans Pharma Ltd on Friday said it has received final approval from the US health regulator for its generic version of Loratadine tablets indicated in the treatment of allergic rhinitis.
The approval by the US Food and Drug Administration (USFDA) is for the company's abbreviated new drug application (ANDA) for Loratadine tablets of strength 10 mg, Marksans Pharma said in a regulatory filing.
Loratadine tablets are indicated for the treatment of allergic rhinitis caused by pollen and upper respiratory tract allergy for over-the-counter (OTC) use. This product is a generic version of Clartin tablet in the same strength as Bayer Healthcare, the company added.
Loratadine is an antihistamine that treats symptoms such as itching, runny nose, watery eyes, and sneezing from "hay fever" and other allergies, it added.
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