As an AP-rated therapeutic equivalent, Gablofen® (baclofen injection) can be substituted for Lioresal® Intrathecal (baclofen injection).
| Similarities | Gablofen | Lioresal |
|---|---|---|
| Formulation | baclofen, sodium chloride and water | baclofen, sodium chloride and water |
| FDA Approved | Yes | Yes |
| Stability and Pump Compatibility | Approved for 180 days in SynchroMed® II Programmable pumps | Approved for 180 days in SynchroMed® II Programmable pumps |
| Concentrations | 50, 500 and 2,000 mcg/mL baclofen |
50, 500 and 2,000 mcg/mL baclofen |
| Refill Kit | Provided with orders | Provided with orders |
| Differences | Gablofen | Lioresal |
| Packaging | Ready to use vials Prefilled syringes |
Glass ampules |
| Distribution | Available direct from CNS Therapeutics and major drug wholesalers | Available through direct ordering only. |
| Novation GPO Partnership | Yes | No |
| Premier GPO Partnership | Yes | No |
Gablofen® (baclofen injection) is indicated for use in the management of severe spasticity of cerebral or spinal cord origin. (View full prescribing information.) Gablofen can be substituted for Lioresal® Intrathecal (baclofen injection) in the same standard concentrations (50 mcg/mL, 500 mcg/mL, and 2,000 mcg/mL).
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).