FDA APPROVES MYLAN'S GENERIC COPD DRUG

Mylan Laboratories announced that Mylan Pharmaceuticals has received final approval from the FDA for its abbreviated new drug application for albuterol sulfate extended-release (ER) tablets, 4 and 8 mg.

The product is the generic version of Dava Pharmaceutical's VoSpire ER, which had U.S. sales of approximately $19 million for the 4- and 8-mg strengths during the 12-month period ending in September 2006, according to IMS Health.

VoSpire ER is a bronchodilator indicated for the relief of bronchospasm in adults and children 6 and older with reversible obstructive airway disease, such as asthma, chronic bronchitis, and other chronic obstructive pulmonary diseases (COPD).

Mylan said it will begin shipping the product immediately.