Drug Approval | October 18, 2022
Zydus receives tentative approval from USFDA for Valbenazine capsules
Valbenazine Capsules had annual sales of US $781 million in the United States according to IQVIA data
Valbenazine Capsules had annual sales of US $781 million in the United States according to IQVIA data
Extended Phenytoin Sodium Capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures
DSCO has requested WHO to share at the earliest with CDSCO the report on establishment of causal relation to death with the medical products in question etc.
Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
Amantadine Extended-Release capsules had annual sales of US $2.7 million in the United States according to IQVIA data
Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urinary incontinence, urgency, and frequency
Sugammadex is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India
Cariprazine is an atypical antipsychotic indicated for the treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar I disorder
The group now has 322 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 2003-04
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