Drug Approval | November 09, 2024
Lupin receives tentative approval from USFDA for Raltegravir Tablets
This product will be manufactured at Lupin’s Nagpur facility in India
This product will be manufactured at Lupin’s Nagpur facility in India
The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature
Diltiazem Hydrochloride Extended-Release Capsules USP are indicated for the treatment of hypertension
Fludrocortisone acetate tablets will be produced at the Group's manufacturing site at Moraiya, Ahmedabad
VYALEV is the first and only subcutaneous 24-hour continuous infusion of levodopa-based therapy for the treatment of motor fluctuations in advanced Parkinson's disease
Indoco is comprehensively working on the remedial action plan
HYMPAVZI’s approval is based on Phase 3 study results demonstrating substantial bleed reduction compared to routine prophylaxis
Paliperidone extended-release tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad
Approval is based on Phase III INAVO120 results, showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting
The company can now expand its business horizon into the area of pharmaceutical applications in the USA
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