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
Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations
NUBEQA is currently indicated for the treatment of adult patients with mHSPC in combination with docetaxel and for non-metastatic castration-resistant prostate cancer (nmCRPC)
Teliso-V is an investigational antibody-drug conjugate (ADC) for patients with previously treated nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression
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
Dupixent is indicated for the approximately 300,000 adults in the US with inadequately controlled COPD and an eosinophilic phenotype
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