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FDA Clears Aurobindo’s Over-the-Counter Allergy Drug

Aurobindo Pharma has received the final approval for its over-the-counter-drug, Cetirizine Hydrochloride solution 1mg/ml from the FDA.

Cetirizine Hydrochloride solution 1mg/ml is the generic equivalent of McNeil Consumer Healthcare Children’s Zyrtec Oral solution for allergy, 1mg/ml, and Children’s Zyrtec Oral solution for hives relief, 1mg/ml.

Cetrizine Hydrochloride solution is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children above two years of age, and falls under the anti-allergic segment. Other indications include relief from itching due to hives. The product is due to be launched.

Earlier in December 2009, the company received final approval under prescription category for Cetirizine Hydrochloride syrup 1mg/ml.

India-based Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s product portfolio encompasses Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, and Anti-Allergics.