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baclofen

Generic: BACLOFEN·Brand: BACLOFEN, FLEQSUVY, GABLOFEN, KEMSTRO, LIORESAL, LYVISPAH, Lioresal, Lyvispah, OZOBAX, OZOBAX DS

baclofen: sourced relationships with 1 company · 3 FDA decisions.

baclofen evidence translation

What we can confirm

What it means

Source-backed records connect baclofen to MAIA; that link alone does not prove the drug works.

What to watch

Watch for new trials or company disclosures after the FDA record.
BioSniper AIPage evidence connected

Prepared research question

How could baclofen → MAIA affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

Dated Pipeline Records (1)
CompanyDated record stage
MAIA Biotechnology, Inc. (MAIA)
Reported 2019-07-30 · Current development: unknownSource
Approved
FDA Decisions3 records
ApprovalINDICATIONS AND USAGE 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 Baclofen Injection 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(MAIA)FDA ↗
ANDA210777UNKNOWNStandardOtherInjectable
Approval(MAIA)FDA ↗
ANDA210048UNKNOWNStandardOtherInjectable
Approval1 INDICATIONS AND USAGE Baclofen injection is indicated for use in the management of severe spasticity in adult and pediatric patients age 4 years and above. 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 baclofen injection via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience i(MAIA)FDA ↗
ANDA210315UNKNOWNStandardOtherInjectable

Frequently asked questions

Which companies have sourced relationships with baclofen?

baclofen has dated SEC/FDA relationship records for MAIA Biotechnology, Inc..

What is baclofen's latest FDA decision?

The most recent tracked FDA decision for baclofen is Approval for INDICATIONS AND USAGE 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 Baclofen Injection 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, dated January 15, 2021.