As we know July was a record breaking month for approvals as reported here, but it was also a record shattering month for Complete Response Letters, beating the October 2017 previous total of 325 with a whopping 357 CRLs. This may be a little disturbing as the trend in FY 2018 is for an overall increase in CRLs. This could mean one of three things: the OGD is not able to meet the GDUFA II goal dates and gets to the point of issuing the CRL; the compliance folks might not be able to get all the required inspections done in time; or the industry is not able to respond to all of the information requests and discipline review letters by the required dates. Perhaps OGD will explain this increase at the fall AAM meeting?
Refuse-to-receive letters ties a low for FY 2018 with just five (one GDUFA II standard ANDA, three priority review ANDAs, and one GDUFA I ANDA (first one in four months – must be an oldie that OGD could not decide on until now).
OGD sent out acknowledgement letters for seventy ANDAs in July. Of interest is that of the ninety-six record-breaking full approvals, sixteen were first-cycle approvals and, of the thirty tentative approvals, four were issued in the first review cycle.
With the exception of a FY record 241 amendments submitted to ANDAs in July, most of the other numbers fall in line with numbers we have been seeing this FY.