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Depomed is taking the FDA to court, claiming the agency violated federal laws and its own regulations when it denied the company’s orphan drug Gralise seven years of marketing exclusivity.
Astellas Pharma has filed an NDA for tacrolimus extended-release capsules to prevent organ rejection in adult kidney transplant recipients and adult male liver transplant recipients.
Indian government health authorities have until today to decide if the government will add price controls to generic medicines beyond the 74 drugs already under price regulation – the latest development in a 17-year dispute over which essential medicines are subject to price controls.
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