USFDA22 Nov 2024, 05:39 pm
Marksans Pharma Limited Receives USFDA Approval for Loratadine Tablets USP 10 mg
AI Summary
Marksans Pharma Limited has announced the final approval of their Abbreviated New Drug Application (ANDA) for Loratadine Tablets USP 10 mg by the USFDA. These 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 Bayer Healthcare's Clartin tablet in the same strength. Loratadine is an antihistamine that treats symptoms such as itching, runny nose, watery eyes, and sneezing from 'hay fever' and other allergies.
Key Highlights
- Marksans Pharma Limited receives USFDA approval for Loratadine Tablets USP 10 mg
- Product is a generic version of Bayer Healthcare's Clartin tablet in the same strength
- Indicated for the treatment of allergic rhinitis caused by pollen and upper respiratory tract allergy for over-the-counter (OTC) use
- Loratadine is an antihistamine that treats symptoms such as itching, runny nose, watery eyes, and sneezing from 'hay fever' and other allergies