Medtech Petitions FDA for Permission to Change Dosage in ANDA for Generic Excedrin

Medtech petitioned the FDA to allow the company to submit an ANDA for generic Excedrin in which the proposed product is in a dosage form different from the reference drug.

The FDA may approve an ANDA with a dosage form different from the reference-listed drug unless its safety and effectiveness also differ, the changes would require major labeling changes, or the agency has determined the RLD has been withdrawn for safety and effectiveness reasons.

In a Feb. 9 citizen petition, the company requested permission to submit an ANDA for a combination of 250mg acetaminophen, 250mg aspirin and 65mg caffeine for over-the-counter migraine treatment.