Lupin Pharmaceuticals (LPI), a US subsidiary of India-based Lupin, has launched its generic Rabeprazole Sodium delayed-release tablets, 20mg. Earlier, the company had received final approval from the US Food and Drug Administration (FDA) ...
Tags: Lupin Pharma, tablets
The US FDA has cleared Eisai's ACIPHEX Sprinkle (rabeprazole sodium) as 12-week gastroesophageal reflux disease (GERD) therapy for use in children between one to eleven years age. The approval was based on positive data from multicenter, ...
Tags: FDA, Disease Therapy for Children, Medicine
Eisai's Aciphex (rabreprazole sodium) has met the FDA's Written Request requirements for pediatric exclusivity in US. Having met FDA's requirement, the company has now gained an additional 6 months US market exclusivity for Aciphex, which ...
Tags: rabreprazole sodium, FDA, Aciphex, pediatric drug, GERD Drug