Generic of 505(b)(2)

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).