Lupin’s Goa plant receives EIR from US FDA
FDA changes inspection classification of the facility to Voluntary Action Indicated
FDA changes inspection classification of the facility to Voluntary Action Indicated
The tablets are available in 150 mg and 225 mg strengths in bottle count sizes of 30 and 90.
Saroglitazar Mg is an investigational compound in the USA, and is yet to be approved by the U.S. Food & Drug Administration (USFDA) or European Medicines Agency (EMA)
Gland Pharma believes that they are amongst one of the first to file for this product and may be eligible for 180 days of generic drug exclusivity
Evusheld is a combination of two long-acting monoclonal antibodies and is the only antibody therapy authorised in the US to prevent Covid-19
Dr. Reddy's valsartan tablets, USP are available in 40 mg in bottle count size of 30, and 80 mg, 160 mg and 320 mg tablets in bottle count sizes of 90
Philips Patient Monitors IntelliVue MX750 and IntelliVue MX850 pair with advanced software and services to offer clinical decision support, continuous, scalable patient management and enhanced infection control
This is the fourth facility from the company to receive this registration
The investigational compound, GZR18, is a novel analogue of glucagon-like peptide-1 (GLP-1), an incretin hormone responsible for many glucoregulatory effects
Expanded EUA includes both treatment of patients with Covid-19 and post-exposure prophylaxis (PEP) in high-risk pediatric and infant patients
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