Ranbaxy Pharmaceuticals, a wholly-owned subsidiary of Ranbaxy Laboratories Limited of New Delhi, India, announced today that RLL has received approval from the U. S. Food and Drug Administration to manufacture and market Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg (24-Hour Formulation).
The Division of Bioequivalence has determined Ranbaxy's Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg (24-Hour Formulation) to be bioequivalent to the listed drug, Claritin-D(R) 24-Hour Extended Release Tablets of Schering Corporation. Total sales of $64.5 million (IRI - MAT: July 2004) were achieved for this product, sold in the OTC market.
Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg are indicated for the temporary relief of symptoms due to hay fever or other upper respiratory allergies, nasal congestion, runny nose, sneezing, itchy and watery eyes, and itching of the nose or throat. The combination also reduces swelling of nasal passages, temporarily relieves sinus congestion and pressure, and temporarily restores freer breathing through the nose.
According to Sandeep Parekh, VP of Sales and Marketing for Ohm Laboratories, Inc. ("Ohm"), RLL's U.S.-based subsidiary, "Ohm will again be participating in the launch of another Loratadine formulation, which in this case is Loratadine and Pseudoephedrine Extended Release Tablets, a non- sedating antihistamine drug that will be marketed in the private label or store brand segment of the U.S. healthcare system. This will provide greater access to a combination product with a proven track record of clinical success that will be made available to patients and health plans at an affordable cost through retail outlets. As such, this product will be introduced by the end of October, 2004 to support the demands of the market."