OGD Updates Activities Report of the Generic Drug Program – and Other Tidbits

The Office of Generic Drugs (OGD) has provided additional updates to its April 2017 metrics, as reported in the above-referenced document.  Not much excitement there but notable for another low month of Refuse-to-Receive (8), which should be good news to industry.  In addition, Drug Master File (DMF) reviews hit a low for this fiscal year at 44.  Not unusual, since there are a finite number of new DMFs to review.

Changes being effected (CBE) supplements was close to the 600 mark again (586) and Prior Approval Supplements (PAS)hit a high for FY 2017 so far at 65.  The full April 2017 numbers can be found here.

As far as approvals for May thus far, OGD’s actions appear to be headed higher than in previous months, and with 1 or 2 reporting days left, judging by the publicly available information, it looks like OGD will reach possibly just over 70 full approvals and about 19 or so tentative approvals. If these number play out in the final Activities Report of the Generic Drug Program (which should be released in about a week to 10 days), this will be the most approvals in each month in FY 2017 by a significant margin, and might mean that the throughput is improving.  We can only hope!

As a side note, OGD also approved the first generic Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients.  Approvals for the generic version were issued to four generic companies.  Good news for patients looking to lower prescription drug costs.