We are often asked if a 505(b)(2) application always requires a clinical study (i.e., Phase 2 or 3 in patients). The answer is a resounding NO.
On January 14, 2008 ADVENTRX Pharmaceuticals announced the successful completion of a bioequivalence study that demonstrated similar blood levels and a “statistically significant reduction in injection site reactions”. The company further stated “the FDA has indicated that this single clinical study, should it demonstrate pharmacokinetic equivalence between ANX-530 and Navelbine, would provide sufficient clinical data to support a Section 505(b)(2) NDA.”
There you have it, another example where a well designed Phase 1 study can suffice for 505(b)(2) submission.
Remember though, ADVENTRX will not likely receive any exclusivity for this application because it did not require a clinical study for approval. We are guessing that ADVENTRX will rely on a patent or trade secret to prevent future generic copies. Unlike most other dosage forms, generics must copy an injectable exactly.