Actualités réglementaires
22 sept. 2026•1 min de lecture
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.
Actualités réglementaires
9 sept. 2026•1 min de lecture
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.
Actualités réglementaires
3 sept. 2026•1 min de lecture
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.