Regulatory Updates
Sep 22, 2026•1 min read
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.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Multiple Manufacturing and Labeling Submissions for SLO‑BID (Theophylline 50 mg)
The FDA has approved a series of manufacturing (CMC) and labeling submissions for SLO‑BID, an oral extended‑release theophylline capsule, now listed as discontinued.