Kashiv's Releuko label update approved; Amneal gets cyclophosphamide OK, guaifenesin label change
FDA records show a Releuko labeling supplement approved for Kashiv Biosciences, plus Amneal Pharms actions on cyclophosphamide and Mucus Relief Extended Release.
FDA application records for the week of November 2-4, 2026 include one new labeling action and two prior Amneal Pharms items.
- RELEUKO, filgrastim-ayow, had a labeling supplement, submission number 5, approved under BLA7610821, sponsored by Kashiv Biosciences LLC, with the approval letter dated 2026-11-05 and submission status dated 2026-11-04.
- Amneal Pharms received original approval for ANDA210890 covering cyclophosphamide capsules in 50MG and 25MG strengths2, with the submission status dated 2026-11-02.
- A labeling supplement, submission number 17, was approved for ANDA207342, Mucus Relief Extended Release, covering guaifenesin extended release tablets in 1.2GM and 600MG strengths3, sponsored by Amneal Pharms, with the submission status dated 2026-11-03.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.