Drug Approval | May 25, 2024
Zydus receives final approval from USFDA for Theophylline ER Tablets
Theophylline is used to treat asthma and chronic obstructive pulmonary disease
Theophylline is used to treat asthma and chronic obstructive pulmonary disease
95.7% of patients responded to Breyanzi in the TRANSCEND FL trial
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.
The USFDA has issued 5 observations pursuant to the completion of audit
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