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The combination drug was approved for medical use in the United States in February 2017, where it also is sold under the brand name Qtern. [ 61 ] [ 62 ] In May 2019, the fixed-dose combination of dapagliflozin, saxagliptin, and metformin hydrochloride as extended-release tablets was approved in the United States to improve glycemic control in ...
Canagliflozin is the first SGLT2 inhibitor to be approved for use in the United States. It was approved in March 2013, under the brand name Invokana and it was also marketed throughout the European Union under the same name. [26] [27] Dapagliflozin, (brand name Forxiga), was approved by the EU in 2012, the first SGLT2 inhibitor approved ...
Dapagliflozin/metformin was approved for use in the European Union in January 2014, [3] in the United States in February 2014, [5] [6] and in Australia in July 2014. [7]
AstraZeneca's (AZN) diabetes drug gets approval in Europe for type-1 diabetes as an adjunct to insulin in patients with a BMI greater or equal to 27 kg/m2.
Forxiga ™ (dapagliflozin), First-In-Class SGLT2 That Works Independently of Insulin, Now Approved in European Union for Treatment of Type 2 Diabetes Forxiga, a once-daily oral agent, provides ...
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Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests:
In combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant ...
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