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Thursday, July 18, 2019

FDA OKs Novartis’ generic Farxiga

The FDA tentatively approves Novartis (NVS +3.6%) unit Sandoz’s marketing application for a generic version of AstraZeneca’s (AZN +0.4%) type 2 diabetes med Farxiga (dapagliflozin).
Tentative approval means that the application met the criteria for approval but patent issues need to be resolved before the the agency grants full approval.
Farxiga generated ~6% of the company’s Q1 product sales ($349M/5,465M).

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