Crushing the dreams of the pharmaceutical giant Novartis AG, the US Food and Drug Administration (FDA) has scraped away the company’s launch for Indacaterol, a drug meant for curing lungs related ailments.
The bosses at the FDA have asked for the extended period of three months to go through the findings of the clinical trial that involved indacaterol.
The drug was waivered by the FDA after some safety risks surrounding the medicine cropped up.
Stating in this context, Trevor Mundel, the Head of Development for Novartis, asserted: "This three-month extension reflects discussion at the advisory committee based on the comprehensive clinical program resulting in a large amount of data to be reviewed”.
The drug is basically for the treatment of the chronic obstructive pulmonary disease (COPD).
The findings of the phase III trial were released in March last year and had claimed that the drug was significantly more effective than formoterol that is needed to be taken twice in a day.
It is learnt that COPD is a lethal disease that claims more than 120,000 lives each year.
Interestingly, the drug has been legally approved in Europe and is sold under the name of Onbrez.
