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
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
Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for treatment of schizophrenia
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
Fluoxetine Tabs 60 mg approval solidifies the company's position in the molecule by complementing the recent approval in April 2024 for Fluoxetine 10 mg and 20 mg tablets and Fluoxetine capsules
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