Yesterday, we published a blog (here) regarding the newly issued and revised PSGs. I pointed out one example of something that I hadn’t seen before relative to products subject to ANDA suitability petitions. I thought I’d missed something along the way, but I’m glad to say that, no, I did not!
In an email today from the FDA’s Small Business and Industry Assistance (SBIA) program came the answer! It was a first, and here is the FDA’s explanation:
New and Revised PSGs Based on Approved Suitability Petitions:
Allopurinol Oral Suspension (RLD: ZYLOPRIM Tablet, NDA 016084)
Clonazepam Oral Suspension (RLD: KLONOPIN Tablet, NDA 017533)
Memantine Hydrochloride Orally Disintegrating Tablet (RLD: NAMENDA Tablet, NDA 021487)
Three new PSGs were published based on approved suitability petitions for a new dosage form of the respective RLDs. The PSGs are first of their kind, providing BE options depending on the availability of the designated reference standard. These PSGs will streamline generic drug development efforts for developing ANDAs with an approved suitability petition to overall expand enhanced access to these medications.
It was something new! Glad I’m not slipping! Unfortunately, there is no link to the SBIA email that I received this morning, but the above is copied from that email.
