The generic formulation must be identical in strength, dosage form, and route of administration and must have the same use indications as the original marketed drug.
The generic drug must be bioequivalent to the innovator drug; meet the same batch requirements for identity, strength, purity, and quality; and must be manufactured under the same strict standards required for innovator products.
A breakthrough seizure after a long remission can have significant psychosocial and physical consequences for the epilepsy patient in areas of life such as employment and driving, and could lead to injury.
Antiepileptic drugs have a high potential for central nervous system-related adverse events.
During the titration period, if there is a switch to a generic or if one generic is changed to another when a prescription is refilled, there is a potential for a change in seizure control.
In addition, AEDs must be managed to account for drug interactions with other medications, such as hormonal contraceptives.
In order to market a generic product, companies must submit an abbreviated new drug application (ANDA) to the FDA.Payers, including the government, and formularies, need to reduce healthcare costs. These savings are particularly important for seniors who are on a fixed income.The ANDA process allows manufacturers to sell generic formulations at a lower price than brand name medications.Management regimens may become very complex, with titration sometimes taking weeks in order to avoid adverse effects.Patients need their medication to be consistent during titration so that prescribed changes of dose have predictable consequences.A change in serum concentration of one drug may lead to changes in serum concentrations of co-medications. Excipients and colorants used in generic products may differ from the brand, potentially causing problems.