Drug Approval | 16 October 2024
Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic NSCLC
Enhertu demonstrated clinically meaningful efficacy in previously treated patients
Enhertu demonstrated clinically meaningful efficacy in previously treated patients
GBM affects nearly 13,000 patients annually in the US and approximately 300,000 globally
Lyka has received the CDSCO approval for manufacturing and marketing of Pregabalin Gel 8% w/w
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
WCK 6777 is the only once-a-day drug in global antibiotic pipeline designed for outpatient parenteral antimicrobial therapy
Based on ECHO Phase III trial which demonstrated Calquence combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy
This is used to treat central diabetes insipidus and bedwetting
Alcaftadine Ophthalmic Solution, 0.25% (OTC) is used to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair, and dander
Cetirizine is used for relief of symptoms of hay fever and other allergic conditions
Lamotrigine extended-release tablets are indicated for adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures
This facility underwent an inspection from 15th to 19th July 2024 and has been classified as Voluntary Action Indicated
The product is expected to be launched in Q3FY25
The inspection conducted by EDQM at its Visakhapatnam facility
Enzalutamide Tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad
The observations are of procedural in nature and will be responded to within the stipulated time
The inspection concluded with the issuance of a form 483 with five observations
HSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures
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