Drug Approval | February 20, 2023
Briefs: Neuland Laboratories, Cipla and Zydus
Cipla has received 8 inspectional observations in Form 483
Cipla has received 8 inspectional observations in Form 483
Canagliflozin and Metformin Hydrochloride Tablets had annual sales of US $49.4 million in the United States
Sirolimus Tablets had annual sales of USD 69 million in the United States (IQVIA MAT Dec. 2022)
Bosentan Tablets for Oral Suspension had annual sales of USD 16 mn in the United States (IQVIA MAT Dec. 2022)
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya
The divested brands include Onabet, Halovate, Sorvate, Luligee, Demelan, Aceret, Dosetil, Revize, and Powercort, and their sub-brands
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India
Brexpiprazole is an atypical antipsychotic indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults
Febuxostat tablets had annual sales of USD 32 million in the United States according to IQVIA data (IQVIA MAT Sept. 2022).
Zydus is the first company to receive final approval and launch Topiramate Extended-Release Capsules, USP 25 mg, 50 mg, and 100 mg in the United States.
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