INDICATIONS AND USAGE LIORESAL INTRATHECAL (baclofen injection) is indicated for use in the management of severe spasticity. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. For spasticity of spinal cord origin, chronic infusion of LIORESAL INTRATHECAL via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 14, 1996 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | None posted |
| Jun 17, 1992 | Original applicationNew dosage form · Priority review | Approved | None posted |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 13, 2021 | Supplement 38Manufacturing | Approved | |
| Jan 16, 2019 | Supplement 37Labeling · Standard review | Approved | |
| Dec 22, 2016 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Sep 30, 2016 | Supplement 32Labeling · Standard review | Approved | |
| Jun 7, 2016 | Supplement 29Manufacturing · Priority review | Approved | None posted |
| Nov 19, 2014 | Supplement 31Labeling · Standard review | Approved | |
| Jun 5, 2014 | Supplement 30Manufacturing · Priority review | Approved | None posted |
| Nov 19, 2013 | Supplement 28Labeling · Standard review | Approved | |
| Sep 5, 2013 | Supplement 27Manufacturing · Priority review | Approved | None posted |
| Mar 6, 2013 | Supplement 26Manufacturing · Priority review | Approved | |
| Jan 10, 2013 | Supplement 25Manufacturing · Priority review | Approved | None posted |
| Nov 13, 2011 | Supplement 24Labeling | Approved | |
| Mar 25, 2011 | Supplement 21Labeling · Standard review | Approved | |
| May 8, 2003 | Supplement 20Manufacturing · Priority review | Approved | |
| Jan 17, 2003 | Supplement 19Manufacturing · Priority review | Approved | |
| Dec 10, 2002 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Nov 21, 2002 | Supplement 17Manufacturing · Priority review | Approved | |
| Mar 6, 2002 | Supplement 16Labeling · Standard review | Approved | |
| Mar 6, 2002 | Supplement 14Labeling · Standard review | Approved | |
| May 3, 2001 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Mar 3, 2000 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| May 5, 1999 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Aug 21, 1998 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Aug 21, 1998 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Jun 23, 1998 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Nov 7, 1996 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Jun 14, 1996 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | None posted |
| May 20, 1994 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Jun 17, 1992 | Original applicationNew dosage form · Priority review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
