Apicore Urges FDA to Require Specific Bioanalytical Method for ANDAs
Apicore Pharmaceutical petitioned the FDA to require that any ANDA for Penicillamine capsules should use a specific method to show bioequivalence.
The company, which holds an ANDA for generic penicillamine capsules used to treat excess copper in the body, claimed that its method is superior because it introduces a stabilizing agent to slow the oxidation of penicillamine and provides a more accurate measure of therapeutic penicillamine in the bloodstream.
The method Apicore used in its ANDA for generic Cuprimine capsules in 250 mg doses “overcomes significant drawbacks of the existing bioanalytical methods, and should be used by pending and subsequent applications,” the company said.
Apicore claimed that current methods for measuring therapeutic penicillamine do not accurately measure the medication because they fail to account for degradation after samples are collected.