Drug Approval | December 01, 2023
Eugia Pharma receives USFDA approval for Budesonide Inhalation Suspension
The product is expected to be launched in FY25
The product is expected to be launched in FY25
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
Approval based on results from TOPAZ-1 global Phase III trial and a Chinese patient
Approval based on DESTINY-Lung02 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a confirmed objective response rate of 49% and median duration of response of 16.8 months in previously treated patients
Short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD)
This product is bioequivalent to the reference listed drug (RLD), Nexium 24 HR Delayed- Release Capsules, 2.0mg (OTC), of AstraZeneca Pharmaceuticals
First PARP inhibitor approved in Japan to demonstrate clinically meaningful benefits in combination with a new hormonal agent
Farxiga is expected to have such a strong influence on the market due to the impressive results
The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients
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