The US Food and Drug Administration (FDA), on February 23, finalized its decision approving the therapeutic equivalence of a generic formula of the SGLT2 inhibitor dapagliflozin made by Zydus Pharmaceuticals to the branded version, Farxiga, that is marketed by AstraZeneca.
The FDA added two diversified dose formulations of this generic dapagliflozin, 5 mg and 10 mg, to the company’s record of Celebrated Drug Products With Therapeutic Equivalence Evaluations, a newsletter recurrently identified because the Orange E book. The company’s circulation adopted tentative approval of therapeutic equivalence that it gave to the 2 Zydus formulations in October 2020.
On the other hand, the Zydus formulations of dapagliflozin will likely no longer soon seem on the US market on myth of in October 2021 the corporate failed in its show in US District Court docket to invalidate the patent that AstraZeneca holds on dapagliflozin by 2025 in step with a deliver of “obviousness.” The court brushed apart the Zydus claims and upheld the validity of the patent.
Dapagliflozin, as Farxiga, currently has FDA labeling for plenty of indications: to crimson meat up glycemic control in adults with kind 2 diabetes; to lower the possibility for hospitalization for coronary heart failure in adults with kind 2 diabetes and established cardiovascular illness or plenty of cardiovascular possibility components; to lower the possibility for hospitalization for coronary heart failure in sufferers with coronary heart failure with reduced ejection share; and to lower the possibility for sustained decline in estimated glomerular filtration rate, halt-stage kidney illness, cardiovascular death, and hospitalization for coronary heart failure in adults with chronic kidney illness in distress for development.
Dapagliflozin is indisputably one of four agents from the sodium-glucose cotransporter 2 inhibitor class approved for US advertising. The diversified approved agents within the class are canagliflozin (Invokana, Janssen), empagliflozin (Jardiance, Boehringer Ingelheim), and ertugliflozin (Steglatro, Merck).
Mitchel L. Zoler is a reporter with Medscape and MDedge, primarily based totally within the Philadelphia affirm. @mitchelzoler
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