The Lachman Blog

  Fidaxomicin, like vancomycin, is indicated for treatment of Clostridium difficile-associated diarrhea.  Both drugs are poorly absorbed systemically and treat the condition locally in the gut and intestines. Vancomycin, however, appears to be more soluble that fidaxomicin over the range of physiologically-relevant dissolution media.  The innovator of fidaxomicin submitted a petition, FDA-2015-P-1595 (here) requesting that […]

For many years, innovators have used the petition process to gum up ANDA and 505(b)(2) approval process and hopefully delay FDA clearance of such applications.  Because of this problem, Congress was compelled to pass legislation (the Food and Drug Administration Administration Act [FDAAA] of 2007) to help correct this unintentional impact on generic drug, 505(b)(2) NDAs, […]

Sponsors are required to submit information in their NDA filings to include “the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be […]

I can’t tell you how many times over my 33-year career that firms have asked me how to submit (or what category of supplement, i.e., Changes being Effected (CBE), CBE-30 or Prior Approval Supplements [PAS]) a capsule supplier change would be. I also have heard from many different firms about what changes were allowed by […]

The Office of Generic Drugs (OGD) released its July approval and ANDA receipt data today (here).  So far this FY, OGD has approved 548 original ANDAs or a monthly average of 54.8 (easy to calculate since this is month 10 of the FY).   OGD did say there would be good and bad months for approvals […]