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Blog & Resources Camargo Blog July 16th, 2012

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).



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