Drug Approval | May 13, 2024
Zydus receives final approval from USFDA for Dexamethasone Tablets
Dexamethasone Tablets USP, 1 mg had annual sales of US$ 1.8 mn in the United States (IQVIA MAT March 24)
Dexamethasone Tablets USP, 1 mg had annual sales of US$ 1.8 mn in the United States (IQVIA MAT March 24)
Sevelamer Carbonate Tablets approval consolidates the company's position in the Sevelamer segment
Receives 3 final and 2 tentative product approvals thus far in Q1FY25
The company is committed to address this observation comprehensively within stipulated time
Subcutaneous nivolumab has potential to be the first and only subcutaneously administered PD-1 inhibitor
With this, for all our USFDA facilities, EIRs are in place
Travoprost Ophthalmic Solution USP, 0.004%, is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
TIVDAK is the first antibody-drug conjugate (ADC) to have positive overall survival data for patients with previously treated recurrent or metastatic cervical cancer
The USFDA has issued 5 observations pursuant to the completion of audit
The drug will be manufactured at the group's topical manufacturing facility at Changodar, Ahmedabad (India)
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