Founded by recognized leaders in intrathecal therapies, CNS Therapeutics develops and brings to market safe, high-quality pharmaceuticals for site-specific delivery to the central nervous system.
Gablofen® (baclofen injection) is the first new, easy-to-administer and cost-effective intrathecal baclofen treatment option from CNS Therapeutics.
Ingenuity. Pure and simple.
Gablofen is the result of innovation and invaluable feedback from physicians, pharmacists, nurses and clinicians. We listened. That’s why leading ITB centers are choosing Gablofen® (baclofen injection) as a safe, convenient, and efficient generic option to Lioresal® Intrathecal (baclofen injection).
From rethinking today's intrathecal drugs to exploring promising new treatments, CNS Therapeutics is working to advance intrathecal pharmaceuticals by developing new concentrations of Gablofen, as well as investigating therapies for treating Parkinson’s disease and chronic pain.
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An FDA-approved, AP-rated generic equivalent.
Gablofen® (baclofen injection) can be substituted for Lioresal® Intrathecal (baclofen injection).
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The FDA definition of Therapeutic Equivalence (TE):
Additional information about the definition of therapeutic equivalence and the criteria required for drug products to be considered therapeutically equivalent.
Read more >The FDA definition of Therapeutic Equivalence (TE):
Drug products classified as therapeutically equivalent can be substituted with the full expectation that the substituted product will produce the same clinical effect and safety profile as the prescribed product. Drug products are considered to be therapeutically equivalent only if they meet these criteria:
- They are pharmaceutical equivalents (contain the same active ingredient(s); dosage form and route of administration; and strength.)
- They are assigned by FDA the same therapeutic equivalence codes starting with the letter "A ." To receive a letter "A", FDA
- Designates a brand name drug or a generic drug to be the Reference Listed Drug (RLD)
- Assigns therapeutic equivalence codes based on data that a drug sponsor submits in an ANDA to scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the Reference Listed Drug).