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S-A's Allegra to be OTC

Sanofi-aventis has won approval from the US Food and Drug Administration to market its allergy drug Allegra as an OTC medicine

Sanofi-aventis (S-A) has won approval from the US Food and Drug Administration to market its best-selling allergy drug Allegra (fexofenadine) as an over-the-counter (OTC) medicine in its original prescription strength.

Allegra-D, a formulation of the medicine that adds the decongestant pseudoephedrine, will also be available in its original strength without a prescription, although it will be sold at the pharmacy counter rather than off the retail shelf due to the potential for misuse of pseudoephedrine, which can be used to make methamphetamine.

The OTC products will include Allegra 24-Hour and 12-Hour Tablets for adults and children 12 years of age and older; Children's Allegra 12-Hour Tablets for six years of age and older, and liquid for use in two years of age and older; Children's Allegra 12-Hour Orally Disintegrating Tablets for use in six years of age and older; and Allegra-D 24-Hour and 12-Hour Allergy and Congestion Extended Release Tablets for use in children 12 years of age and older.

The products will be sold at drug, grocery, mass merchandiser and club stores across the US beginning in March. They will be marketed through S-A's Chattem, the OTC-focused company that became a wholly-owned subsidiary of the company in early 2010 through a $1.9bn acquisition. S-A, which is based in France and had no OTC business in the US before buying Chattem, made the acquisition largely in order to have a way to market non-prescription Allegra without having to lose profits to a partner.

"Leveraging our US Consumer Healthcare platform to convert prescription medicines to OTC products is a key growth driver for sanofi-aventis to become a diversified healthcare company in the United States," Hanspeter Spek, president, global operations, S-A, said in a statement.

Prescription Allegra, which is formulated not to cause drowsiness, is the most-prescribed allergy medication in the US and had annual peak sales of €1.5bn before recent patent expirations of some formulations began to cut into profits. The drug will compete in the non-prescription market with Schering-Plough's OTC Claritin (loratadine), which has annual sales of about $400m.

26th January 2011

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