Hawthorn Pharmaceuticals announced the FDA approval of the company's Granisol (granisetron HCl) oral solution. Granisol is an oral solution for the prevention of nausea and vomiting associated with cancer therapy.
Johnson & Johnson announced that it received an approvable letter from the FDA regarding its NDA for ceftobiprole for the treatment of complicated skin and skin structure infections, including diabetic foot infections. J&J along with its co-development partner, Swiss-based Basilea Pharmaceutica, said it is reviewing the agency's letter and will work quickly to resolve any outstanding issues. The NDA for ceftobiprole was submitted to the FDA last May. An application for the use of ceftobiprole in adults in the same indication is currently under regulatory review in Europe, Australia, Canada and in other countries.