The US FDA has approved JB Chemicals & Pharmaceuticals’ Abbreviated New Drug Application (ANDA) for Loratadine Tablets USP 10 mg.
They 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 generic version of Clartin tablet in the same strength of Bayer Healthcare. The company expects to commercialise this product in Q1 of FY 2021-22.