Drug Approval | December 16, 2021
Sun gets US FDA approval for generic amphotericin B injection
It is the first approved generic and is eligible for 180 days of Competitive Generic Therapy exclusivity
It is the first approved generic and is eligible for 180 days of Competitive Generic Therapy exclusivity
FDA changes inspection classification of the facility to Voluntary Action Indicated
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Visby Medical’s instrument-free PCR test to detect the SARS-CoV-2 virus can now be used to pool up to five patient samples using a single test
Extension of hypericin orphan designation beyond cutaneous T-cell lymphoma
The designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with a preserved ejection fraction
The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad.
The company’s RenovoCath Delivery System designed for targeted treatment of solid tumours
Labetalol hydrochloride injection USP is indicated for the control of blood pressure in severe hypertension.
Zydus’ Sitagliptin base contains the active moiety Sitagliptin in a different form than used in the branded reference product, Januvia (Sitagliptin Phosphate)
Metronidazole Gel USP, 1% is indicated for the topical treatment of inflammatory lesions of rosacea
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