Tools / Drug approvals and letters / Drugs Baclofen Manages severe spasticity. Sold as Lioresal, Kemstro, Gablofen, Ozobax, Ozobax Ds and 2 more. Every FDA application for this active ingredient: 7 branded and 42 generic.
As of Nov 13, 2026, FDA lists 49 applications for Baclofen (sold as Lioresal, Kemstro, Gablofen and others), first approved Nov 22, 1977, with 1 new use approved and 2 published complete response letters.
First approved : Nov 22, 1977 Applications : 49 New uses approved : 1 Complete response letters : 2 Medicare spending, 2025 : $108M
Medicare Spending CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name Product Part Spending, 2025 Change Beneficiaries Baclofen Part D $90.9M +3% 1,400,904 Baclofen (J0475) Part B $15.6M -9% 5,992 Lioresal Intrathecal Part D $427K +6% 97 Gablofen Part D $171K +30% 35 Fleqsuvy Part D $165K -57% 22 Ozobax Ds Part D $158K +396% 21 Lyvispah Part D $89K -45% 219 Baclofen (J0476) Part B $2K -41% 18
Clinical Trials 18 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all Study Phase Status Posted Outcomes of Neurosurgical Tone Management Spastic/Dystonic Quadriplegia, Cerebral Palsy (CP) · Boston Children's Hospital — Recruiting Sep 14, 2026 Electrical Neuromodulation for Modifying Spinal Network Involved in Spasticity Spinal Cord Injuries (Complete and Incomplete), Spinal Cord Injury · University of Mississippi Medical Center Not applicable Active, not recruiting Aug 28, 2026 Measuring Pelvic Floor Muscle Fitness Before and After Treatment Myofacial Pain, Pelvic Pain · University of California, Los Angeles Not applicable Not yet recruiting May 26, 2026 Selective Dorsal Rhizotomy as a Cost Effective and Safe Procedure as a Alternative to Intrathecal Baclofen Pump in Patients With Post Traumatic Spasticity Post Traumatic Induced Spasticity · Assiut University Not applicable Not yet recruiting May 13, 2026 Synaptic Mechanisms of Continuous Theta Burst Stimulation in Depression Major Depression · Mclean Hospital Early phase 1 Recruiting May 1, 2026 The Analgesic Efficacy and Safety of Baclofen in Patients With Herpes Zoster Herpes Zoster, Pain · Beijing Tiantan Hospital Not applicable Recruiting Jan 30, 2026 An Artificial Intelligence Driven Approach to Optimize Patient Selection for a Transitional Pain Service Postsurgical Pain Management, Postsurgical Pain, Chronic · University of California, San Francisco Phase 3 Not yet recruiting Dec 22, 2025 Effect of Baclofen in Management of Patients With Gastroesophageal Reflux Disease Symptoms GERD - PPI Non-responders · Adnan Imtiaj Rahul Phase 2 / Phase 3 Recruiting Jul 14, 2025
Applications NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history Approved Application Sponsor Supplements Marketing Nov 22, 1977 Lioresal NDA 17851 · New molecular entity 33 Discontinued Jul 21, 1988 Baclofen ANDA 72234 11 Marketed Jul 21, 1988 Baclofen ANDA 72235 11 Marketed Sep 18, 1991 Baclofen ANDA 72825 10 Discontinued Sep 18, 1991 Baclofen ANDA 72824 11 Discontinued Feb 27, 1992 Baclofen ANDA 73043 8 Discontinued Feb 27, 1992 Baclofen ANDA 73044 8 Discontinued Jun 17, 1992 Lioresal NDA 20075 · New dosage form 28 Marketed Jan 28, 1994 Baclofen ANDA 73092 12 Discontinued Jan 28, 1994 Baclofen ANDA 73093 11 Discontinued Aug 19, 1996 Baclofen ANDA 74584 2 Marketed Aug 20, 1996 Baclofen ANDA 74698 3 Discontinued Oct 30, 2003 Kemstro NDA 21589 · New dosage form 0 Discontinued Jul 29, 2005 Baclofen ANDA 77121 1 Marketed Jul 29, 2005 Baclofen ANDA 77181 1 Discontinued Aug 30, 2005 Baclofen ANDA 77068 1 Marketed Dec 20, 2005 Baclofen ANDA 77241 5 Marketed Aug 14, 2006 Baclofen ANDA 77862 0 Discontinued Oct 26, 2007 Baclofen ANDA 77971 1 Discontinued Oct 31, 2007 Baclofen ANDA 77088 1 Marketed Sep 18, 2009 Baclofen ANDA 78401 6 Marketed Sep 18, 2009 Baclofen ANDA 78504 4 Marketed Feb 18, 2010 Baclofen ANDA 90334 1 Marketed Nov 19, 2010 Gablofen NDA 22462 · New formulation or manufacturer 6 Marketed May 3, 2016 Baclofen ANDA 91193 0 Marketed Nov 28, 2017 Baclofen ANDA 209102 2 Marketed Mar 6, 2018 Baclofen ANDA 209594 3 Discontinued Mar 21, 2018 Baclofen ANDA 209592 0 Discontinued Nov 23, 2018 Baclofen ANDA 211659 0 Marketed Feb 1, 2019 Baclofen ANDA 211555 2 Marketed Jul 30, 2019 Baclofen ANDA 210315 0 Marketed Sep 11, 2019 Baclofen ANDA 210048 0 Marketed Sep 18, 2019 Ozobax, Ozobax Ds NDA 208193 · New dosage form 1 Marketed Jul 9, 2020 Baclofen ANDA 212067 0 Marketed Oct 9, 2020 Baclofen ANDA 212378 2 Marketed Mar 5, 2021 Baclofen ANDA 214374 0 Marketed Jul 13, 2021 Baclofen ANDA 214099 1 Marketed Jul 16, 2021 Baclofen ANDA 214114 1 Marketed Nov 22, 2021 Lyvispah NDA 215422 · New dosage form 0 Discontinued Jan 25, 2022 Baclofen ANDA 215885 0 Marketed Feb 4, 2022 Fleqsuvy NDA 215602 · New dosage form 1 Marketed Feb 22, 2023 Baclofen ANDA 217324 0 Marketed Jun 8, 2023 Baclofen ANDA 217252 0 Marketed Aug 10, 2023 Baclofen ANDA 216309 0 Discontinued Nov 8, 2023 Baclofen ANDA 217687 0 Discontinued Jan 10, 2024 Baclofen ANDA 217788 1 Marketed Dec 6, 2024 Baclofen ANDA 214445 1 Marketed — Baclofen ANDA 71260 0 Discontinued — Baclofen ANDA 71261 0 Discontinued
Complete Response Letters FDA's published letters for these applications Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
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