Drug Approval | November 22, 2023
Lupin receives tentative approval from USFDA for Dapagliflozin Tablets
Dapagliflozin Tablets (RLD Farxiga) had estimated annual sales of USD 7282 million in the US
Dapagliflozin Tablets (RLD Farxiga) had estimated annual sales of USD 7282 million in the US
First-in-class AKT inhibitor has potential to reshape treatment for breast cancer patients
Pitavastatin Tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) and is used in the treatment of seizures.
This approval showcases Teva’s proven strengths in complex generic formulations development and device engineering
The product will be manufactured at Lupin’s Nagpur facility in India
Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy alone
XTANDI becomes the first and only androgen receptor signaling inhibitor approved for use with or without a GnRH analog therapy in nonmetastatic castration-sensitive prostate cancer
The countrywide initiative aims to spread awareness, educate the public & ensure that no one is left behind in the fight against respiratory diseases
Approval based on results from TOPAZ-1 global Phase III trial and a Chinese patient
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