indacaterol

*** Pharmaceuticals A U.S. advisory panel backed the approval of a Novartis lung drug called indacaterol, although at a lower dose than ones used in Europe.

Business Watch 2011

The Food and Drug Administration panel was weighing a drug called indacaterol that Novartis is seeking to sell in the U.S. to treat chronic obstructive pulmonary disease, the fourth-leading cause of death in the U.S. and a multibillion-dollar-a-year market for pharmaceutical companies.

Lung Drug Gets Mixed Verdict Jennifer Corbett Dooren 2011

The Food and Drug Administration panel was weighing a drug called indacaterol that Novartis is seeking to sell in the U.S. to treat chronic obstructive pulmonary disease, the fourth-leading cause of death in the U.S. and a multibillion-dollar-a-year market for pharmaceutical companies.

WSJ.com: What's News US 2011

The U.S. regulator's advisory panel also in early March rejected the medicine's use at a higher dose, a decision that is likely to delay the launch of a promising follow-up lung drug, called QVA149, which combines indacaterol with another medicine.

FDA Extends Review of Novartis Lung Drug Goran Mijuk 2011

The main regulatory concerns about the medicine focus on the novel way that indacaterol treats lung diseases and whether it carries the risk that asthma symptoms can worsen and lead to deaths.

FDA Extends Review of Novartis Lung Drug Goran Mijuk 2011

While indacaterol is widely expected to be approved at a lower dose, Novartis will probably need to relaunch trials for its promising follow-up drug QVA149 to meet U.S. regulatory concerns about the medicine's dosage.

FDA Extends Review of Novartis Lung Drug Goran Mijuk 2011

Chances for a quick approval of Novartis lung drug indacaterol have been quashed by the U.S. Food and Drug Administration, which alerted the Swiss pharma giant it needs three more months to assess the medicine's trial data.

Business Watch 2011

While sales potential for indacaterol is below the $1 billion blockbuster threshold, follow-up drug QVA149 looks set to meet or surpass that level with some analysts saying it could generate peak sale of more than $5 billion.

FDA Extends Review of Novartis Lung Drug Goran Mijuk 2011

Chances for a quick approval of Novartis AG's lung drug indacaterol have been quashed by the U.S. Food and Drug Administration, which alerted the Swiss pharma giant it needs three more months to assess the medicine's trial data.

FDA Extends Review of Novartis Lung Drug Goran Mijuk 2011

Most have already dropped hopes for indacaterol being approved at a higher dose after the U.S. drug panel's verdict in March, even though the FDA isn't required to follow the panel's advice.

FDA Extends Review of Novartis Lung Drug Goran Mijuk 2011