The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Naproxen Sodium Capsules, 220 mg, of Bionpharma
The product will be manufactured at Lupin's facility in Goa, India.
The OAI classification implies that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
The study concluded that elevated levels of two proteins help predict how a person will recover from a traumatic brain injury (TBI), providing important information to determine appropriate care
Meclizine Hydrochloride Tablets had estimated annual sales of USD 29 million in the U.S.
The approved product has an estimated market size of around US$ 606 million for the twelve months ending June 2022, according to IQVIA.
Collaboration focuses on developing and implementing real-world research to drive patient access to cancer medicines
Use of IVUS recommended in all phases of lower extremity arterial and venous revascularization procedures to guide clinical decisions
Xofluza is the first and only single-dose oral medicine for the treatment of influenza to be approved in the US for children as young as five years of age
MeitY will provide technical support for digitalisation of the Ayush Sector under the Ayush Grid project for a period of three years
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