Drug Approval | August 27, 2021
Aurobindo subsidiary, Eugia gets US FDA approval for Cyclophosphamide injection
The product will be available in 500 mg/2.5 mL and 1 g/5 mL vials
The product will be available in 500 mg/2.5 mL and 1 g/5 mL vials
The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks
The data suggest that a booster dose given within 6 to 12 months after the second dose may help maintain a high level of protection against COVID-19.
The approval is based on a multi-centre, single-arm, open-label pivotal clinical trial
If approved it will bring a second source of MMR vaccine to the US market
The company has also applied to DCGI for Emergency Use Authorization (EUA) for ZyCoVD, the world's first Plasmid DNA Vaccine
A veteran in cell therapy and oncology commercialisation
Pegfilgrastim has estimated annual sales of USD 3.66 billion in the U.S. (IQVIA MAT December 2020).
Dr. Sharvil Patel cites the example of prescriptions being handed over to patients despite unavailability of enough stock of such medicines
With the surge of infections in India in the recent days AmphoTLC will address the country's acute liposomal amphotericin B shortage
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