Drug Approval | October 01, 2024
Apitoria Pharma gets Form 483 with 10 observations from USFDA
The observations are of procedural in nature and will be responded to within the stipulated time
The observations are of procedural in nature and will be responded to within the stipulated time
HSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures
A first-in-class muscarinic agonist for the treatment of schizophrenia in adults
Enzalutamide Capsules will be produced at the Group’s manufacturing site at Moraiya, Ahmedabad
Doses will be ready to ship to applicable European Union (EU) member states as soon as possible upon European Commission (EC) authorization
Glenmark Pharmaceuticals Limited has informed that the USFDA has issued Form 483 with zero observations
USFDA concludes inspection of Dr. Reddy's Laboratories R&D centre in Bachupally with zero observation
Positive opinion granted for KEYTRUDA plus chemotherapy for the first-line treatment of adult patients with primary advanced or recurrent endometrial carcinoma
Bumetanide Injection USP (RLD Bumex) had estimated annual sales of USD 20 million in the U.S.
This approval is backed by a decade of proven safety and efficacy data of Ocrevus® IV, with over 350,000 people treated globally
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