In its Monday statement, pertaining to its application submitted to the US Food and Drug Administration (FDA) for the approval of its lung drug QAB149, or indacaterol, Swiss drugmaker Novartis AG said that the FDA has sought additional information on the dosage proposed for the drug.

According to Novartis, the once-a-day indacaterol drug treats adult patients of chronic obstructive pulmonary disease (COPD), commonly called "smoker's lung."

To begin with, Novartis will market the drug a 'monotherapy,' but industry analysts opine that the drug's full sales potential will largely be dependent on coalescing it with other available treatments.

Having earlier claimed that QAB149 was one of its most promising experimental drugs, Novartis Monday said that it would work with the FDA to assess the already-submitted data for the drug, along with the most current data to ascertain whether further clinical trials were necessary.

Commenting on the latest development, Trevor Mundel, Novartis Pharma AG's Global Head of Development, said: "Our confidence in the benefit/risk profile of QAB149 is based on results of Phase III trials which showed QAB149 significantly improved lung function."

Saying that QAB149 will eventually help it generate over $1 billion in yearly sales, the company added that the drug had last month received the recommendation for approval from the FDA's European Union counterpart.