JB Chemicals gets USFDA nod for generic product

The US Food and Drug Administration (USFDA) has approved company's abbreviated new drug application (ANDA) for Loratadine tablets USP 10 mg for treatment of allergic rhinitis caused by pollen and upper respiratory tract allergy, JB Chemicals and P...

NEW DELHI: JB Chemicals and Pharmaceuticals on Friday said it has received approval from the US health regulator to market Loratadine tablets, used to treat allergies, in the American market.

The US Food and Drug Administration (USFDA) has approved company's abbreviated new drug application (ANDA) for Loratadine tablets USP 10 mg for treatment of allergic rhinitis caused by pollen and upper respiratory tract allergy, JB Chemicals and Pharmaceuticals said in a regulatory filing.

JB Chemicals' product is a generic version of Bayer Healthcare's Clartin tablets.


"The company expects to commercialise this product in the first quarter of 2021-22 and is expected to improve its US sales," the drug firm noted.
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