Mylan Pharma gets USFDA nod for Breyna for Generic Version of Symbicort

Viatris President Rajiv Malik added: "The momentous FDA final approval of Breyna is further evidence of our well-established development expertise and proven ability to move up the value chain with more complex products by leveraging our robust scientific capabilities to target gaps in healthcare and patient needs. This approval also builds on our past successes of bringing other complex product firsts to market and demonstrates the continued delivery of our strong pipeline."

This approval presents an opportunity for Viatris to launch Breyna in 2022 as the upcoming court proceedings develop. In December 2021, the U.S. Court of Appeals for the Federal Circuit reversed the infringement judgment against Viatris and ordered the case remanded back to the U.S. District Court for the Northern District of West Virginia for further proceedings.

Aaron Mann, CEO of Kindeva Drug Delivery, added: "We are pleased that Viatris has received full FDA approval for this important respiratory product. This important milestone is reflective of our sustained commitment to inhalation and complex drug delivery, from technical formulation, clinical program management, and regulatory submission, and I'm grateful to my many Kindeva colleagues for their contributions."

The full indication for Breyna includes asthma in patients six years of age and older; and the maintenance treatment of airflow obstruction and reducing exacerbations for patients with COPD, including chronic bronchitis and/or emphysema. COPD is a term used to describe chronic lung diseases and is characterized by breathlessness; it affects more than 16 million Americans. Asthma causes swelling of the airways resulting in difficulty breathing, and approximately 25 million Americans have the chronic condition.

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