USFDA Shifts Claritin To OTC Category

New Delhi, November 28: | Updated: Nov 29 2002, 05:30am hrs
The US Federation Drug Authority has shifted the $3.2 billion blockbuster anti-histamine drug Claritin (salt name: loratadine) from prescription to over-the-counter category.

The verdict has come as a major boost to Delhi-based Morepen Laboratories Ltd which is the only Indian and second company in the world to have got the US Federation Drug Authority (USFDA) approval for the drug.

Morepens chairman and managing director Sushil Suri confirmed to FE that the shifting of the drug from prescription to OTC will result in a long-term gain for the company.

We stand to gain in a big way as the drug will now become a common product and a sustainable growth driver for us. It will no longer remain a 6-month bonanza.

However, he declined to comment about the price realisation and the price behaviour of the drug, which is going off-patent on December 19, 2002. But a company said Morepen has pending shipment order for the US market to the tune of Rs 45-50 crore.

FDA has approved claritin (loratadin) as an OTC allergy product. Previously available only as a prescription drug, Claritin is approved for seasonal allergic rhinitis - a condition that causes runny nose, nasal congestion, sneezing and itchy nose, throat, eyes and ears.

By making it easier to get this widely-used drug, todays (Wednesdays) action will enable many people to get less-sedating, effective relief for their allergy symptoms more quickly and at low cost, Mark B McClellan, Commissioner of Food and Drugs has been quoted as saying on the FDA website.

This approval reflects FDAs commitment to bringing prescription drugs to the OTC market when they can be safely used without a prescription, he stated.

Claritin approval for OTC marketing was based on FDAs criteria for determining appropriate drugs for OTC use- namely that the drug in question treats a condition that consumers can diagnose and manage themselves; that the drug is sufficiently safe for use by consumers without direct prescriber supervision; and that the drugs label explains potential adverse effects and conditions of use with clear and understandable directions.

According to Mr Suri, The ruling of the US court to convert Claritin (loratadine) into over the counter (OTC) product is very positive for us.