Considering the importance and cost-effectiveness of generic drugs, the world is increasingly inclining toward them. The USFDA also encourages the development of high-quality and low-cost generic products and grants special approval to such drug products. In one such initiative, the FDA has approved a generic drug formulation for the treatment of bronchospasms. FDA recently granted its first generic drug approval to albuterol sulfate inhalation aerosol indicated to treat and prevent bronchospasms due to reversible obstructive airway disease and to prevent exercise-induced bronchospasms .

The drug is approved for administration in patients aged four and above. It is to be used in combination with metered-dose inhalers. The albuterol sulfate inhalation aerosol is a “complex generic.” Complex generics are the generic counterparts of branded drugs that have complex formulations and modes of…