Actualizaciones regulatorias
Novedades regulatorias de FDA, EMA, TGA y organismos globales
#Buprenorphine ×
Actualizaciones regulatorias
22 sept 2026•1 min de lectura
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.
Actualizaciones regulatorias
9 sept 2026•1 min de lectura
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.
Actualizaciones regulatorias
3 sept 2026•1 min de lectura
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.