DAVA Pharmaceuticals, Inc., Fort Lee, NJ, Sept. 21, (DDMAC).(HUMAN DRUGS & DIETARY SUPPLEMENTS)

Warning Letter Bulletin | October 1, 2006 | Copyright

FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) reviewed a sample request letter for DAVA's VoSpire ER (albuterol sulfate) and deemed the letter false and misleading in that it presented claims for VoSpire ER but failed to communicate any risks associated with its use. Moreover, some of the claims it presented were unsubstantiated effectiveness claims.

According to the FDA-approved PI, VoSpire ER is "indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease."

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