Proposal to Have Empagliflozin as Option for Children with Type 2 Diabetes
Manufacturers of Jardiance, which contains the drug empagliflozin, which is used in the treatment of diabetes in adults, seeking approval in the US to make a version of the medicine to meet increasing demand from this group of young diabetes patients.
April 19, 2023
by SHEM OIRERE
Lupin gets tentative USFDA nod for empagliflozin and metformin hydrochloride ER tablets
They are indicated as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus.
January 8, 2021
by expresspharma
Zydus Cadila gets tentative USFDA nod for empagliflozin and linagliptin tablets
They are oral diabetes medicines that help control blood sugar levels.
September 18, 2020
by expresspharma
Empagliflozin reduced risk of death and hospitalisation for heart failure by 25 per cent in adults
Boehringer Ingelheim announced the full results from the EMPEROR-Reduced Phase III trial in adults with heart failure with reduced ejection fraction, with and without diabetes.
August 31, 2020
by expresspharma
Alembic Pharma gets tentative nod from USFDA for Empagliflozin and Linagliptin tablets
Empagliflozin and Linagliptin tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
August 28, 2020
by expresspharma
Empagliflozin meets primary endpoint in Phase III heart failure trial
It reduced the risk of cardiovascular death or hospitalisation for heart failure versus placebo on top of standards of care in adults with heart failure with reduced ejection fraction.
July 31, 2020
by expresspharma
Lupin receives US FDA’s tentative approval for Empagliflozin and Linagliptin Tablets
Empagliflozin and Linagliptin Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
July 24, 2020
by expresspharma
Alembic Pharmaceuticals receives US FDA’s tentative approval for Empagliflozin and Metformin Hydrochloride Tablets
The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Synjardy Tablets of Boehringer lngelheim Pharmaceuticals.
July 21, 2020
by expresspharma
Zydus gets tentative USFDA approval for empagliflozin and metformin hydrochloride tablets
It will be manufactured at the group’s formulations manufacturing facility at SEZ in Ahmedabad.
May 4, 2020
by expresspharma
Zydus receives tentative nod from USFDA for Empagliflozin Tablets
The medication is used to improve blood sugar control in adults with Type 2 diabetes mellitus, along with diet and exercise.
April 13, 2020
by expresspharma
Boehringer, Lilly Get Complete Response Letter for Empagliflozin
FDA is unable to approve sNDA for Empagliflozin in type 1 diabetes.
March 24, 2020
by contractpharma
FDA Grants Fast Track Designation to Empagliflozin for Chronic Heart Failure
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to empagliflozin for the reduction of the risk of cardiovascular death and hospitalization for heart failure in people with chronic heart failure ...
June 28, 2019
by americanpharmaceuticalreview