FDA Explains How It Counts To 30 Months

02 Feb 2015

Agency rejects Sandoz’s assertion that the 30-month period for securing ANDA tentative approval under the MMA’s forfeiture provisions begins to run on the date an application is submitted.

The 30-month period during which an ANDA first-filer must obtain tentative approval or face forfeiture of its rights to 180-day marketing exclusivity begins to run on the day after the application is filed, FDA said in a Jan. 26 citizen petition response.

In a June 2012 petition, Sandoz Inc. challenged Ranbaxy Laboratories Ltd.’s eligibility for generic marketing exclusivity on