URL, MUTUAL APPLY FOR APPROVAL OF GENERIC MUCINEX

United Research Laboratories (URL) and Mutual Pharmaceutical have filed an abbreviated new drug application seeking approval to market Mutual's guaifenesin extended-release tablets, 600 mg and 1,200 mg. The drug is the generic version of Adams Respiratory Therapeutics' Mucinex. According to Adams, Mucinex is one of the most widely recommended OTC products to treat chest congestion and coughs.

Mutual is pursuing a strategy that will result in either extremely low-priced generic guaifenesin or a deal with a large OTC pharma company. The company is in discussions with several pharma companies about their possible interest in launching guaifenesin extended-release tablets as branded products. Mutual also is aggressively pursuing the development of a line of guaifenesin combination products, such as ones with with pseudoephedrine or dextromethorphan.