Marketing Authorization of Generic Drugs and Challenges

A. Lavanya¹, M. Usha Harika², Dr. M.Kishore Babu³, Dr. P.V. Murali Krishna^4
1Assistant Professor, Krishna Teja Pharmacy College, Tirupati, Andhra Pradesh.
²Krishna Teja Pharmacy College, Tirupati, Andhra Pradesh.
³Principal, Krishna Teja Pharmacy College, Tirupati, Andhra Pradesh.
⁴Associate professor, MNR College of Pharmacy College, Sangareddy, Hyderabad, Telangana.

A B S T R A C T
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA’s Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use.  All approved products, both innovator and generic, are listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).Generic drug applications are termed “abbreviated” because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness.  Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug).  One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy, volunteers.  This gives them the rate of absorption, or bioavailability, of the generic drug, which they can then compare to that of the innovator drug.  The generic version must deliver the same amount of active ingredients into a patient’s bloodstream in the same amount of time as the innovator drug.