MYLAN'S TOLMETIN APPROVED IN USA

13 June 1993

Mylan Laboratories has received approval from the US Food and Drug Administration to manufacture and market a generic version of McNeil's Tolecton (tolmetin sodium). McNeil is a subsidiary of Johnson & Johnson.

Tolmetin is a non-steroidal anti-inflammatory drug which is widely-used in the treatment of rheumatoid arthritis and osteoarthritis. The approval is for a 400mg capsule formulation of tolmetin, according to Mylan.

Sales of the branded version of tolmetin are in the region of about $70 million a year, although Mylan is not the first generics company to get approval for a non-branded form A version developed by IVAX Pharmaceuticals was approved by the FDA a few months ago. Tolmetin lost its patent protection in 1992.

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