規制動向

FDA、EMA、TGA および世界の規制動向

#Buprenorphine ×

2026年9月22日•1分で読めます

FDA Approves Buprenorphine ANDA078633 Sublingual Tablets

FDA has approved an ANDA for buprenorphine sublingual tablets (2 mg and 8 mg) from Hikma Pharmaceuticals USA Inc., with associated labeling and REMS submissions.

2026年9月9日•1分で読めます

FDA Submissions for Sublingual Buprenorphine Hydrochloride Tablets (Products 001 & 002)

FDA records show two discontinued sublingual buprenorphine tablet products with multiple approved labeling and REMS submissions spanning 2010‑2026.

2026年9月3日•1分で読めます

FDA Approves ANDA210272 for Buprenorphine Transdermal Patch

The FDA has approved application ANDA210272 for a buprenorphine transdermal patch, covering five dosage strengths and requiring a REMS program.