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Amneal submits ANDA for generic of ProAir HFA albuterol MDI

Amneal Pharmaceuticals announced that it has submitted ANDAs for three complex generics, including a generic version of Teva’s ProAir HFA albuterol sulfate metered dose inhaler. Currently, the only listed therapeutic equivalent for ProAir HFA is Lupin’s generic, which was approved by the FDA in 2020.

Amneal Co-CEOs Chirag and Chintu Patel commented, “We continue to make excellent progress advancing our pipeline of complex, high-value medicines. The filing of applications for three new complex generics are additional proof points in our successful innovation journey. Today, about 90% of our generics R&D pipeline is made up of complex products. As we move up the value chain of product complexity, we are adding new and sustainable long-term growth drivers to our diversified portfolio.”

The company also recently submitted an ANDA for a generic version of Narcan nasal spray.

Read the Amneal Pharmaceuticals press release.

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published on July 28, 2023

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