Generic of 505(b)(2)
- Posted by: Ken Phelps
- Published on: July 16, 2012
There are not many instances of a generic version of a reference drug approved via the 505(b)(2) pathway. Last Friday, FDA approved Watson’s generic of Teva’s Plan
B One-Step [progestin]. Watson will call its version Next Choice One Dose.
For history and industry buffs, Plan B was originally developed under the Duramed brand Barr Pharmaceuticals, then led by Paul Bisaro. Now Paul is head of Watson and Barr is a part of Teva. Of course, I and a couple key members of my staff were part of Duramed.
Plan B was originally approved under 505(b)(2).