Indoco Remedies has announced that it has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride Tablets USP, 10 mg (OTC). The product is a generic equivalent of the Reference Listed Drug, Zyrtec Allergy Tablets, 10 mg, produced by Johnson & Johnson Consumer Inc.
The approved Cetirizine Hydrochloride Tablets USP, 10 mg will be manufactured by Indoco at its facility located in Verna Industrial Area, Goa, India. Cetirizine is commonly used for the relief of symptoms related to hay fever and other allergic conditions.
Commenting on the approval, Aditi Panandikar, Managing Director of Indoco Remedies, stated, “This approval is a testament to Indoco’s commitment to delivering high-quality and affordable healthcare solutions to global markets. We are proud to contribute to providing effective allergy relief medicines and remain focused in expanding our portfolio in the OTC space.”