New Delhi, Dec 31 (UNI) Leading pharmaceutical firm Ranbaxy Laboratories Ltd (RLL) today said it has received the final approval from US Food and Drug Administration to manufacture and market Cetirizine Hydrochloride Tablets (OTC).
'' The company can manufacture and market OTC in 5 mg and 10 mg,'' said a company statement.
The total annual market sales for Cetirizine Hydrochloride Tablets accounts for about 1.3 billion dollars.
Cetirizine Hydrochloride is used 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.
''We are pleased to receive this final approval for OTC. This OTC product formulation further expands our portfolio of affordable generic alternatives and will be launched immediately to all classes of trade,'' said RLL subsidiary Ohm Laboratories Inc Vice President (Sales and Distribution) Jim Meehan.
Ohm, based in New Jersey, is a wholly-owned subsidiary of RLL and is engaged in the sale and distribution of generic and branded private label, OTC products in the US healthcare system.