Determination That BILTRICIDE (Praziquantel) Oral Tablet Was Not Withdrawn for Safety or Effectiveness
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
The FDA has confirmed that the 600 mg oral tablet of BILTRICIDE was not removed from sale due to safety or effectiveness concerns. As a result, generic versions of this drug can still receive approval from the FDA. This decision clarifies the situation for generic drug manufacturers looking to produce equivalents of BILTRICIDE, and ensures the continued availability of this medication for treating specific parasitic infections.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- FDA confirms BILTRICIDE was not withdrawn for safety/effectiveness
- Approval for generic versions continues
- No impact on drug availability
Obligations
What this law requires
ANDA applicants must demonstrate that generic praziquantel 600 mg oral tablets have the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and labeling as the listed drug product
ANDA applicants must establish bioequivalence to the listed drug product (BILTRICIDE praziquantel 600 mg oral tablet)
FDA must maintain BILTRICIDE (praziquantel) oral tablet, 600 mg, in the 'Discontinued Drug Product List' section of the Orange Book
FDA must continue to approve ANDAs referring to BILTRICIDE (praziquantel) 600 mg oral tablets as long as they meet all legal and regulatory requirements
FDA must not begin procedures to withdraw approval of already-approved ANDAs that refer to BILTRICIDE (praziquantel) oral tablet, 600 mg