Sun Pharma logs eleven FDA labeling supplements and two REMS updates in one week
FDA records show Sun Pharma affiliates received approvals for labeling changes across isotretinoin, metformin, spironolactone and combination products, plus REMS updates for buprenorphine products.
Sun Pharma and its affiliated sponsors received a cluster of FDA approvals dated 2026-08-11 and 2026-08-14, covering labeling supplements on eleven applications and REMS-related supplements on two buprenorphine products.
- A labeling supplement for Absorica (isotretinoin) capsules under NDA021951, covering strengths from 10mg to 40mg, was approved with a submission status date of 2026-08-11.1
- A companion labeling supplement for Absorica LD (isotretinoin) capsules under NDA211913, spanning strengths from 8mg to 32mg, was also approved with a submission status date of 2026-08-11.2
- Riomet ER (metformin hydrochloride extended-release oral suspension) under NDA212595 received a labeling supplement approval, with a submission status date of 2026-08-11.3
- A labeling supplement for spironolactone tablets (25mg, 50mg, 100mg) under ANDA089424 was approved, with a submission status date of 2026-08-11.4
- Metformin hydrochloride tablets (500mg, 850mg, 1GM) under ANDA076038 received a labeling supplement approval, with a submission status date of 2026-08-11.5
- Metformin hydrochloride extended-release tablets (500mg) under ANDA077124 received a labeling supplement approval, with a submission status date of 2026-08-11.6
- Metformin hydrochloride tablets (500mg, 850mg, 1GM) under ANDA075967 received a labeling supplement approval, with a submission status date of 2026-08-11.7
- Glipizide and metformin hydrochloride combination tablets under ANDA077620 received a labeling supplement approval, with a submission status date of 2026-08-11.8
- Metformin hydrochloride extended-release tablets (500mg, 750mg) under ANDA077336 received a labeling supplement approval, with a submission status date of 2026-08-11.9
- A REMS-related supplement for sublingual buprenorphine hydrochloride tablets (2mg, 8mg) under ANDA201760 was approved, with a submission status date of 2026-08-14.10
- A REMS-related supplement for combination buprenorphine hydrochloride and naloxone hydrochloride sublingual tablets under ANDA201633 was approved, with a submission status date of 2026-08-14.11
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.