New Delhi, Apr 25 (UNI) Pharma major Ranbaxy Laboratories Ltd (RLL) today said it has received the final approval from the US Food and Drug Administration (USFDA) to manufacture and market Cetirizine Hydrochloride Oral Solution.
The Office of Generic Drugs, USFDA, has determined the Ohm formulation to be bio-equivalent and have the same therapeutic effect as that of the reference-listed drug Children's Zyrtec Oral Solution (Allergy) and Children's Zyrtec Oral Solution (Hives-Relief), 1mg/mL of McNeil Consumer Healthcare, a comapny statement said.
Total annual market sales for Cetirizine Hydrochloride Syrup as a prescription only product, was 157 million dollars as in December 2007.
Cetirizine Hydrochloride is indicated for the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies.
Other indications include relief from itching due to hives (urticaria).
''This product formulation further expands our portfolio of affordable generic alternatives and will be launched immediately to all classes of trade participating in the OTC private label market,'' said US-based Ohm Laboratories Vice President (Sales and Distribution) Jim Meehan.
Ohm Laboratories is a wholly-owned subsidiary of Ranbaxy and is engaged in the sale and distribution of generic and branded private label, OTC products in the US healthcare system.
UNI SR BJR DB2016