Difference Between Generic ANDA and 505(b)(2) Submissions
In the pharmaceutical industry, both generic (ANDA) and 505(b)(2) submissions are key regulatory pathways, but they serve different purposes. Generic (ANDA): This is for drugs that are bioequivalent to an already approved product. ANDA submissions must show the drug is the same in dosage, form, strength, and administration route as the reference drug. No new…
