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DAVA Pharmaceuticals, Inc., Fort Lee, NJ, Sept. 21, (DDMAC).

Publication: Warning Letter Bulletin
Publication Date: 01-OCT-06 		Format: Online
Delivery: Immediate Online Access
Full Article Title: DAVA Pharmaceuticals, Inc., Fort Lee, NJ, Sept. 21, (DDMAC).(HUMAN DRUGS & DIETARY SUPPLEMENTS)

Article Excerpt
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...

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