AB Rating 505b2 NDA Generic

FDA Grants AB Rating to 505b2 NDA Generic

FDA recently granted a therapeutic equivalence (TE) rating of AB to a “generic” version of an innovator product approved via a 505b2 NDA.  In July 2014, FDA granted the AB rating to Perrigo’s 1% testosterone gel drug product (NDA 203098) approved in January 2013, and a BX rating to Teva’s (NDA 202763) approved in February 2012. …

PDG to attend FDA’s OTC Public Hearing

The agency recently announced a public hearing to “obtain input on a new paradigm we are considering. Under this paradigm, the Agency would approve certain drugs that would otherwise require a prescription for nonprescription use (also known as over-the-counter or OTC) under conditions of safe use.” Please let us know if you plan to attend…

Regulatory Affairs Updates: Latest on ANDA User Fees (GDUFA)

FDA and industry leaders have agreed on legislation that, if passed by Congress, will usher in user fees for ANDA sponsors. As currently drafted, a one-time backlog fee is anticipated for “Each person that owns an abbreviated new drug application (ANDA) that is pending on October 1, 2012, and that has not received a tentative…