Teva gets ANDA approval for sugammadex sodium injection; four mycophenolate REMS updates cleared
FDA approved Teva's original ANDA for sugammadex sodium and signed off on REMS-related supplements across four existing mycophenolate applications.
Teva Pharmaceuticals had five FDA actions post in the week ending July 29, 2026, covering one new drug approval and four supplemental updates to existing mycophenolate products.
- Sugammadex sodium received original approval under ANDA214126, covering intravenous solution products at strengths of 500MG base per 5ML and 200MG base per 2ML (both equal to 100MG base per ML)1. The submission status date is listed as 2026-07-28.
- Mycophenolate mofetil for oral suspension (200MG/ML), under ANDA211272, received approval of a REMS-class supplement (Supplement 4)2.
- Mycophenolate mofetil tablets at 500MG strength, under ANDA065457, had a REMS-class supplement (Supplement 19) approved3.
- Mycophenolate mofetil capsules at 250MG strength, under ANDA065491, had a REMS-class supplement (Supplement 34) approved4.
- Mycophenolate sodium delayed-release tablets, in strengths equal to 360MG and 180MG base, under ANDA202720, had a REMS-class supplement (Supplement 12) approved5.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.