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2011 505(b)(2) Approvals Now Exceed 505(b)(1) NDA Approvals

What a year for 505(b)(2) drug development!  In 2011 FDA approved 44 505(b)(2) NDA submissions.  Various authors have reported that FDA approved 34 or 35 drugs in 2011 (505(b)(1) NDA + BLA).  I had speculated a couple of years ago that perhaps 80% of new drugs approved  in 2012 would be 505(b)(2)’s, based on botha  declining new drug approval and an increase in 505(b)(2)’s.  In fact, the new drug approvals increased from 2010.

In 2011, FDA approved 33 new formulations, 1 New Molecular Entity, 7 new combinations and 3 formerly unapproved drugs.  I have listed the approvals by these categories in my annual scorecard.

Of the 33 pharmaceutical companies obtaining approvals, Hospira was the most active 505(b)(2) sponsor in 2011 with 5 approvals, followed by Sandoz with 4 approvals.  Abbott, Cypress, Prostrakan each had 2 approvals.  All of the other sponsors had one approval.

The careful observer will note that apparently the same product was approved for more than one sponsor.  It turns out that these products are injectables and there are differences in excipients that ensure that they are not the “same” product.