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BioWorld - Tuesday, January 27, 2026
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Dec. 8, 2016
Kitov Pharmaceuticals Holdings Ltd., of Tel Aviv, Israel, said lead drug candidate, KIT-302, met the FDA standards to establish six-month stability. The study, conducted by Kitov's manufacturing partner, Dexcel Pharma, showed that nine pivotal batches of KIT-302 – three in each dosage form (celecoxib/amlodipine of 200 mg/10 mg, 200 mg/5 mg and 200 mg/2.5 mg) – met six-month stability criteria, enabling the inclusion of registration batches in the company's new drug application submission, planned for the first quarter of 2017.
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