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Aurobindo Pharma Limited is pleased to announce that it has received the final approval for Cetirizine Hydrochloride Solution 1mg/mL (OTC) from the US Food & Drug Administration (USFDA)
Andhra Pradesh, India | February 1, 2010 | Aurobindo Pharma Limited is pleased to announce that it has received the final approval for Cetirizine Hydrochloride Solution 1mg/mL (OTC) from the US Food & Drug Administration (USFDA). This approval of Cetirizine Hydrochloride Solution is under over-the-counter (OTC) product category.
Cetirizine Hydrochloride Solution 1mg/mL is the generic equivalent of McNeil Consumer Healthcare Children's Zyrtec Oral Solution (Allergy), 1 mg/mL, and Children's Zyrtec Oral Solution (Hives Relief), 1 mg/mL. Cetrizine Hydrochloride Solution is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children above 2 years of age and falls under the Anti-Allergic segment. Other indications include relief from itching due to hives. The product will be launched shortly.
Aurobindo has a total of 111 ANDA approvals (83 Final approvals and 28 Tentative approvals) from USFDA
About Aurobindo Pharma Limited:
Aurobindo Pharma Limited (www.aurobindo.com), headquartered at Hyderabad, India, manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company's manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, WHO, Health Canada, MCC South Africa, ANVISA Brazil. The company's robust product portfolio is spread over 6 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, and Anti-Allergics, supported by an outstanding R&D set-up. The Company is marketing these products globally, in over 125 countries.
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SOURCE: Aurobindo Pharma Limited |
