Drug Approval | 13 May 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
The product is used to treat amyotrophic lateral sclerosis
Subcutaneous nivolumab has potential to be the first and only subcutaneously administered PD-1 inhibitor
The Unit currently caters to emerging markets of Latin America and Africa with a variety of dosage forms
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.
ORACEA is a trademark of Galderma Holdings, S.A.
Eugia Pharma Specialities receives 7 observations from USFDA for Unit II
TIVDAK is the first antibody-drug conjugate (ADC) to have positive overall survival data for patients with previously treated recurrent or metastatic cervical cancer
Colchicine Capsules are indicated for prophylaxis of gout flares in adult
Recommendation based on CAPItello-291 results which showed the Truqap combination reduced the risk of disease progression or death by 50%
Glenmark’s Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC), will be distributed in the U.S. by Glenmark Therapeutics, USA
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)
If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU
If approved in the European Union, Fruquintinib will be the first novel targeted therapy for Metastatic Colorectal Cancer regardless of biomarker status in over a decade
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