Drug discovery and new product innovation in medical science have always paved new ways for serving humanities. However, this journey of introducing any new medicine to the market is actually not that easy as it sounds. The authoritarian regulations make it quite hard for pharmaceutical companies to make that new drug’s commercialization possible. In fact, the generic forms of drugs too take years to come to the marketing platform. The recent case of Perrigo, Catalent to gain the generic of Teva Inhaler is the finest example of this time taking process. It almost took four tries over four years, though Perrigo has finally reached the finish line with its generic of Teva’s tricky-to-make ProAir HFA inhaler for the treatment of COPD (chronic obstructive pulmonary disease) and asthma.
The US FDA (Food and Drug Administration) has finally approved the first generic of ProAir HFA (albuterol sulfate) Inhalation Aerosol which is intended for the treatment as well as the prevention of bronchospasm in patients aging four years and above with reversible obstructive airway disease along with the prevention of exercise-induced bronchospasm in patients with the same age group. Perrigo and its manufacturing partner Catalent touted the news jointly today, saying they are releasing a limited supply now of the generic albuterol sulfate inhalation aerosol and ramping up production for a steady supply by the fourth quarter of 2020. Adding to this, the inhaler has been approved for the patients of four years and above for both, the cure as well as the prevention of bronchospasm with reversible obstructive airway disease. It is also for purpose of prevention of exercise-induced bronchospasm.
Catalent president of oral and specialty delivery, Jonathan Arnold, said in a statement, “This is a significant technical achievement for both parties, as it is the first generic metered-dose inhaler to be approved by the FDA in over 20 years”.
