Are Gablofen® (baclofen injection) and Lioresal® Intrathecal (baclofen injection) the same and is Gablofen listed in the Orange Book?
Yes. Gablofen is now listed in the FDA Orange Book as an AP-Rated branded generic, with Lioresal as the reference listed drug. This means that Gablofen can be substituted for Lioresal. The chemical formulations of Gablofen and Lioresal are identical, with the same labeled amount of baclofen for each concentration, and the same physiologic concentration of the same salt (0.9% sodium chloride) mixed together in water. Each milliliter of Gablofen or Lioresal contains baclofen USP 50 mcg, 500 mcg, or 2,000 mcg; and sodium chloride (9 mg) in preservative-free sterile water for injection. No other components are added to these drugs. Both products are sterile, pyrogen-free, isotonic solutions free of antioxidants, preservatives, or other potentially neurotoxic additives. Both products are commercially available and indicated only for intrathecal administration.
Are Gablofen and Lioresal bioequivalent?
Yes. Gablofen and Lioresal are bioequivalent. Both are parenteral solutions intended for intrathecal injection with the same active and inactive ingredients in the same concentrations. Bioequivalent products have the same clinical effect and safety profile when administered as indicated.
Is Gablofen approved by the FDA for use in the Medtronic SynchroMed® II Programmable Pump? Has it been thoroughly tested in that pump?
Yes. Gablofen has been rigorously tested and found to be stable in and compatible with the SynchroMed® II Programmable Pump. Gablofen was incubated in SynchroMed pumps at 37° C for 6 months, and the drug remained within specifications for concentration, purity, and degradation, and the SynchroMed pumps were found to function well within the manufacturer's specifications. This 6-month “in-pump” testing was reviewed by the FDA, and Gablofen was approved for use in the SynchroMed II Programmable Pump or other pumps labeled for intrathecal administration of Gablofen (View full prescribing information for Gablofen). All users should refer to the pump manufacturer's manual and follow the specific instructions and precautions for programming the pump and/or refilling the reservoir.
Is a code available to bill for Gablofen?
Yes. CNS Therapeutics has agreements with both Medicare and Medicaid, and Gablofen is now listed in the major drug databases. Gablofen is a branded, generic intrathecal baclofen, and you can use existing reimbursement codes. For more information on reimbursement, please contact us.
Is Gablofen covered under Medicare Part D?
Yes. Gablofen is now listed for coverage under the Medicare Part D prescription drug plan, effective May 1, 2011. Lioresal® Intrathecal (baclofen injection) is currently not covered under the Medicare Part D prescription drug plan.
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).
An FDA-approved, AP-rated generic equivalent.
Gablofen® (baclofen injection) can be substituted for Lioresal® Intrathecal (baclofen injection).
Compare >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).