Drug Approval | October 04, 2024
Indoco Remedies receives final ANDA approval from the USFDA for Cetirizine Hydrochloride Tablets
Cetirizine is used for relief of symptoms of hay fever and other allergic conditions
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
The product is expected to be launched in Q3FY25
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
HSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures
The inspection concluded with the issuance of a form 483 with five 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
Enzalutamide Capsules will be produced at the Group’s manufacturing site at Moraiya, Ahmedabad
Subscribe To Our Newsletter & Stay Updated
