Success Stories

Camargo Success Stories

Camargo has worked with a number of clients who have initiated 505(b)(2) projects on their own – and with consultants who were new to 505(b)(2) – and have run into missteps. In the following case studies, we document situations we have encountered, and how Camargo helped pull these misaligned projects back on track. Some inconsequential details have been changed to protect proprietary information.


Success Story 1

A European generic API producer needs to offset declining revenues


Success Story 2

Knowledge of combination drugs and target markets leads to commercial success


Success Story 3

This strategy allows for earlier approval and protection against generic competition


Success Story 4

Full NDA approval without conducting any clinical studies using the 505(b)(2) pathway


Success Story 5

Mid-tier generic company facing declining revenues and weak outlook due to the generic patent cliff.


Success Story 6

Using competitor’s product in a Phase 2 trial offsets the need to conduct one of the Phase 3 trials


Success Story 7

Inadequate use of public information leads to costly study requirements


Success Story 8

Inadequate use of public information leads to clinical holds

Success Story 9

Time- and Money-Saving Strategy

Success Story 10

Orphan Drug Designation on the Second Attempt

Success Story 11

Drug Delivery Technology – New Gold-Standard of Treatment