BWAAHAHAHAHAHAH ! NOVARTIS COULD FUCK UP A WET DREAM !!!!
UDPATE 1-U.S. FDA approves low dose of Novartis lung drug
* Approves 75 mcg dose of Arcapta Neohaler
* Novartis hoped for 150 mcg dose approval
WASHINGTON, July 1 (Reuters) - U.S. health regulators on Friday approved a new lung medicine by Novartis (NOVN.VX), but in a lower dose, creating a roadbump for the Swiss drugmaker in its development of a potentially lucrative new drug.
In line with its advisory panel's vote in March, the U.S. Food and Drug Administration approved a 75 mcg dose of Arcapta Neohaler, an inhalation powder indacaterol for treating chronic obstructive pulmonary disease (COPD), which is also known as smoker's cough and is the third-leading killer of Americans.
Indacaterol is a once-a-day, long-acting beta agonist, or LABA, a type of drug used to open airways in patients with asthma or COPD. Other LABAs are taken twice a day.
Novartis and Glaxo are racing to sell a two-in-one medicine that combines a LABA with long-acting muscarinic antagonist (LAMA) to produce a more effective, convenient therapy.
For Novartis to develop such drug, it needed approval for a higher 150 mcg dose of Arcapta Neohaler, which is sold as a a single therapy in Europe under the brand name Onbrez Breezhaler and had revenue of $33 million in 2010.
The 150 microgram dose of Arcapta Neohaler failed to win support from a U.S. advisory panel earlier this year as it urged Food and Drug Administration approval of a 75 microgram dose of the inhaled drug, unconvinced that the higher dose provided any additional benefit.
UDPATE 1-U.S. FDA approves low dose of Novartis lung drug
* Approves 75 mcg dose of Arcapta Neohaler
* Novartis hoped for 150 mcg dose approval
WASHINGTON, July 1 (Reuters) - U.S. health regulators on Friday approved a new lung medicine by Novartis (NOVN.VX), but in a lower dose, creating a roadbump for the Swiss drugmaker in its development of a potentially lucrative new drug.
In line with its advisory panel's vote in March, the U.S. Food and Drug Administration approved a 75 mcg dose of Arcapta Neohaler, an inhalation powder indacaterol for treating chronic obstructive pulmonary disease (COPD), which is also known as smoker's cough and is the third-leading killer of Americans.
Indacaterol is a once-a-day, long-acting beta agonist, or LABA, a type of drug used to open airways in patients with asthma or COPD. Other LABAs are taken twice a day.
Novartis and Glaxo are racing to sell a two-in-one medicine that combines a LABA with long-acting muscarinic antagonist (LAMA) to produce a more effective, convenient therapy.
For Novartis to develop such drug, it needed approval for a higher 150 mcg dose of Arcapta Neohaler, which is sold as a a single therapy in Europe under the brand name Onbrez Breezhaler and had revenue of $33 million in 2010.
The 150 microgram dose of Arcapta Neohaler failed to win support from a U.S. advisory panel earlier this year as it urged Food and Drug Administration approval of a 75 microgram dose of the inhaled drug, unconvinced that the higher dose provided any additional benefit.