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Aug 14, 2026Weekly roundup

Amneal clears five FDA supplements: REMS update on buprenorphine/naloxone leads week

FDA approved a REMS-class supplement for Amneal's buprenorphine/naloxone sublingual tablets, alongside labeling updates for metformin, spironolactone, and doxycycline.

Amneal Pharmaceuticals had five FDA supplement approvals clear this cycle, spanning one REMS update and four labeling changes.

  • FDA approved a REMS-class supplement (SUPPL 59) for Amneal's buprenorphine hydrochloride and naloxone hydrochloride sublingual tablets under ANDA203136, covering strengths of EQ 8MG BASE with EQ 2MG BASE and EQ 2MG BASE with EQ 0.5MG BASE1, with a submission status date of 2026-08-14.
  • FDA approved a labeling supplement (SUPPL 39) for Amneal's extended-release metformin hydrochloride tablets under ANDA078596, covering 500MG and 750MG strengths2, dated 2026-08-11.
  • FDA approved a labeling supplement (SUPPL 32) for Amneal's metformin hydrochloride tablets under ANDA077880, covering 500MG, 850MG, and 1GM strengths3, dated 2026-08-11.
  • FDA approved a labeling supplement (SUPPL 28) for Amneal's spironolactone oral tablets under ANDA091426, covering 25MG, 50MG, and 100MG strengths4, dated 2026-08-11.
  • FDA approved a labeling supplement (SUPPL 24) for Amneal's doxycycline hyclate 100MG oral capsules under ANDA2072895, dated 2026-08-11.

Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.