On Monday, 14th February 2022, Cadilla Healthcare Ltd said that, its US arm Zydus Pharmaceuticals Inc. has now received the final approval from the US FDA for the purpose marketing the company’s generic version of the Roflumilast tablets having the strength of 500 mcg that has been initiated for the purpose of decreasing the risk of the chronic obstructive pulmonary disease (COPD) exacerbations.
The company ‘Zydus Pharmaceuticals’, as being one of the first applicants for the Roflumilast Tablets of strength of 500 mcg has been eligible for 18 days of the shared exclusivity of the generic drug as said by the company during their filing.
The company also said that, the Food and Drug Administration (FDA) of the United States has also given a tentative approval for the tablets of 250 mcg. The Roflumilast tablets have also been indicated as a treatment for the purpose of decreasing the risk of COPD exacerbations in the patients suffering from serious COPD associated with the chronic bronchitis along with a history of exacerbations.
The company is now having around 327 approvals and so far the company has filed more than 400 (ANDAs) abbreviated new drug applications since the commencement of the process of filing in the financial year of 2003-2004.
