Drug Approval | 29 September 2024
Briefs: Lupin, Alembic Pharmaceuticals and Piramal Pharma
Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations
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
The product is an additional formulation of Cresemba Capsule 100 mg and Cresemba Intravenous Infusion 200 mg
MVA-BN approved for use against mpox and smallpox in adolescents 12-17 years of age after expedited review with EMA
New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids
Glenmark Pharmaceuticals Limited has informed that the USFDA has issued Form 483 with zero observations
USFDA concludes inspection of Dr. Reddy's Laboratories R&D centre in Bachupally with zero observation
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
New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids
Eugia Steriles receives EIR from USFDA for new injectable facility
Tecentriq Hybreza provides patients and physicians with greater flexibility of treatment options while showing safety and efficacy consistent with intravenous
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
The USFDA inspection focused on evaluating the facility's adherence to global regulatory requirements and best practices
Jubilant HollisterStier is a subsidiary of Jubilant Pharma Holding
The recent inspection covered both cGMP and PAI processes
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