Indoco Remedies Gains US FDA Approval for Generic Cetirizine Tablets
Key Insights
Indoco Remedies received US FDA approval for its generic Cetirizine Hydrochloride Tablets USP, 10 mg (OTC).
The generic drug is equivalent to Johnson & Johnson's Zyrtec Allergy Tablets (search), 10 mg, offering a more affordable option.
Cetirizine is commonly used to alleviate symptoms associated with hay fever (search) and various allergic conditions (search).
Indoco Remedies has secured final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride Tablets USP, 10 mg (OTC). This approval allows Indoco to manufacture and market a generic version of Zyrtec Allergy Tablets (search), 10 mg, produced by Johnson & Johnson Consumer Inc.
The approved Cetirizine Hydrochloride Tablets USP, 10 mg, will be produced at Indoco's manufacturing facility located in Verna Industrial Area, Goa, India. Cetirizine is an antihistamine widely used for the symptomatic relief of hay fever (search) and other allergic conditions (search), providing relief from symptoms such as sneezing, runny nose, itchy eyes/nose/throat, and skin rashes.
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 on expanding our portfolio in the OTC space.”
The approval marks a significant step for Indoco Remedies in expanding its presence in the over-the-counter (OTC) medication market. By offering a generic alternative to Zyrtec, Indoco aims to provide a cost-effective option for consumers seeking relief from allergy symptoms. Allergic rhinitis, commonly known as hay fever (search), affects a substantial portion of the population, and affordable treatment options are crucial for managing its symptoms effectively.