Teva gets FDA approval for generic tofacitinib citrate ER; two Claravis labeling supplements cleared
Teva Pharms USA received FDA sign-off on an original ANDA for tofacitinib citrate extended-release tablets and two labeling supplements for Claravis isotretinoin capsules.
Teva's regulatory activity for the week centers on one new generic approval and two label updates for an existing acne drug.
- Teva Pharms USA received approval for a new ANDA (209813) covering tofacitinib citrate extended-release tablets in 22mg and 11mg base strengths, with the approval dated 2026-08-17.1
- A labeling supplement (SUPPL 69) for Claravis (isotretinoin) capsules under ANDA076135, covering the 20mg, 30mg and 40mg strengths, was approved on 2026-08-21, with Teva Pharms USA as sponsor.2
- A separate labeling supplement (SUPPL 63) for Claravis 10mg isotretinoin capsules under ANDA076356 was also approved on 2026-08-21, with Teva Pharms USA as sponsor.3
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.