Novartis said the U.S. Food and Drug Administration requested additional information on the dosing proposed for the drug candidate, indacaterol, which is also known as QAB149. Novartis said it will work with the FDA to review data already submitted on QAB149, as well as recent data to determine what, if any, further clinical trials would be required.
Monday, October 19, 2009
Novartis - clinical trials, ain't they a bitch?!
Novartis suffered a setback Monday for one of its most promising experimental drugs after the U.S. health regulator said it wanted more information on the proposed dosage for the Swiss drug maker's smoker's cough treatment.
Novartis said the U.S. Food and Drug Administration requested additional information on the dosing proposed for the drug candidate, indacaterol, which is also known as QAB149. Novartis said it will work with the FDA to review data already submitted on QAB149, as well as recent data to determine what, if any, further clinical trials would be required.
Novartis said the U.S. Food and Drug Administration requested additional information on the dosing proposed for the drug candidate, indacaterol, which is also known as QAB149. Novartis said it will work with the FDA to review data already submitted on QAB149, as well as recent data to determine what, if any, further clinical trials would be required.
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