規制動向

FDA、EMA、TGA および世界の規制動向

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2026年9月9日•1分で読めます

FOSPHENYTOIN SODIUM (ANDA078736) FDA Approval

FDA approves the original ANDA and multiple labeling supplements for fosphenytoin sodium injection (product 001) by Pharmobedient.

2026年8月24日•1分で読めます

FDA Approves ANDA078070 for Valacyclovir Hydrochloride Tablets by Pharmobedient

The FDA approved application ANDA078070 submitted by Pharmobedient for oral valacyclovir hydrochloride tablets (500 mg and 1 g equivalents). Both products are listed as discontinued.