Drug Approval | December 18, 2023
Zydus receives final approval from the USFDA for Lacosamide Tablets
Lacosamide is indicated to treat partial-onset seizures
Lacosamide is indicated to treat partial-onset seizures
Darunavir is a protease inhibitor antiviral medicine that prevents Human Immunodeficiency Virus (HIV-1) from multiplying in the body
Cyclophosphamide is a chemotherapy medication that slows the growth of cancer cell
The product will be manufactured at Lupin's Pithampur facility in India
Cresemba is the only azole antifungal therapy approved for pediatric patients as young as one affected by these serious, potentially life-threatening infections
Approximately 16,000 patients 12 years of age and older with severe sickle cell disease may now be eligible for this one-time treatment
Methylene blue is a cationic thiazine dye that necessitates specialised capabilities and expertise to develop and manufacture the product
This product will be manufactured by Indoco Remedies at their manufacturing facility located at Goa
Ivabradine Tablets, 5 mg and 7.5 mg had annual sales of USD 136.5 mn in the United States
The company has received Form 483 with three observations
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