Post-Approval Studies Of Novartis’ TOBI Podhaler May Focus On Long-Term Efficacy
Novartis’ TOBI Podhaler, intended to manage cystic fibrosis patients infected with Pseudomonas aeruginosa, passed FDA’s Anti-Infective Drugs Advisory Committee on an overwhelming vote, but lingering concerns remained.
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Gathering more data to assuage concerns about possibly lower efficacy in black patients will be key to converting the accelerated approval to full approval for the tuberculosis drug, FDA’s Anti-Infective Drugs Advisory Committee concludes.
Less than a year after signing a consent decree to resolve compliance problems, the company is forced to stop manufacturing its generic version of the best-selling cholesterol drug. For FDA, the issue poses a public relations challenge since it touches on several areas where the agency has recently been criticized – generic drug quality, manufacturing oversight and drug shortages.
FDA’s Anti-Infective Drugs Advisory Committee was fully satisfied with “sputum culture conversion” as a surrogate endpoint for accelerated approval, but turned back a last-minute question from FDA on traditional full approval for the tuberculosis drug bedaquiline.