Perrigo Company plc and Catalent Pharma Solutions have recently announced the attainment of ANDA (abbreviated new drug application) approval from the U.S. FDA for a generic version of ProAir® HFA.
Perrigo will initially launch the AB-rated, generic albuterol sulphate inhalation aerosol in a limited quality, with an aim to begin steady supply of the product by Q4 of 2020. After the successful launch, the over-the-counter pharmaceutical products manufacturer and Catalent are partnering to increase the production process of the new ProAir® HFA to cater to future demand.
The recently created albuterol sulphate inhalation aerosol, which is a generic version of ProAir® HFA, is a medication that can be used for the treatment and prevention of bronchospasm and reversible obstructive airway disease in patients who are 4-years old and above. It can also be used to reduce and prevent the shortness of breath caused by exercise-related bronchospasms.
Sharon Kochan, EVP & President, Rx Pharmaceuticals, has reportedly stated that the collaborative agreement that the two companies signed a decade ago has resulted in the launch of the recent first-to-market generic version of this inhaler. She further commented that the FDA approval can be attributed to the companies’ product development strategy as well as their teams’ commitment to bringing new, specialized, low-cost products to the market.
Jonathan Arnold, Catalent’s President, Oral and Specialty Delivery, also commented on the significant technical achievement of both parties, as the AB-rated version of the albuterol sulfate inhalation aerosol is the first generic inhaler to gain FDA approval in over 20 years. He also added that this approval is testament to Catalent’s clinical-scale production capabilities and complements their extensive product development for various portfolio of inhalers such as Dry-Powder and Metered-Dose inhalers as well as the combination of unit dose or bi-dose nasal drug spray combination products.
According to recent estimates, the gross sales of ProAir® HFA have been recorded at over $1.4 billion.