Drug Approval | February 14, 2022
Zydus gets 180 days of shared exclusivity for Roflumilast tablets
The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad
The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad
Immune responses were about two-to-three-fold higher in adolescents than in adults against all variants studied. Vaccine was well-tolerated with no safety signals identified
Key takeaways of recent quarter & conference call highlights
It has a total of 50 ANDA approvals from USFDA
The pharma division’s domestic business generated turnover of Rs. 219.85 crore for the last financial year
Pegfilgrastim is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients receiving chemotherapy
Glenmark’s current portfolio consists of 173 products authorized for distribution in the U.S. marketplace and 46 ANDA’s pending approval with the U.S. FDA
According to IQVIA sales data for the 12-month period ending November 2021, the Ziac tablets, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg market achieved annual sales of approximately US $ 30.3 million
Go-ahead for pivotal clinical trial which is expected to commence by March
Vigabatrin is an anticonvulsant. It is known to work by stopping the breakdown of a natural calming substance (GABA) in the brain
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