The Hindu Business Line : Ranbaxy gets FDA nod for respiratory drug

RANBAXY Laboratories Ltd is set to challenge Schering Corp's Claritin-D tablets providing temporary relief from hay fever and other respiratory allergies.

Ranbaxy has received approval from the US Food and Drug Administration (FDA) to manufacture and market its combination drug - Loratadine and Pseudoephedrine Sulfate extended-release tablets, 10 mg/240 mg (24-Hour Formulation).

The Division of Bioequivalence has determined Ranbaxy's combination drug to be bioequivalent to the listed drug, Claritin-D 24-hour extended-release tablets manufactured by Schering Corporation.

The total sales of Claritin-D are about $64.5 million, which is sold in the over-the-counter (OTC) market.

Loratadine and Pseudoephedrine Sulfate extended-release tablets are indicated for the temporary relief of symptoms due to hay fever or other upper respiratory allergies, runny nose, sneezing, itchy and watery eyes, 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 Mr Sandeep Parekh, Vice-President, Sales and Marketing, Ohm Laboratories Inc, a wholly owned subsidiary of Ranbaxy, "Ohm will again be participating in the launch of another Loratadine formulation.

These tablets will be marketed in the private label or store brand segment of the US healthcare system.

This will provide greater access to a combination product with a proven track record of clinical success that will be made available at an affordable cost to patients through retail outlets.

As such, the product will be introduced by the end of October to support the demands of the market."

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