FDA Announces Approval of Brand Name Change

As we reported here back in July 2015, FDA has warned patients and healthcare professionals about a potential look-alike, sound-alike naming issue with an antidepressant Brintellix (vortioxetine) and Brilinta (ticagrelor), a blood thinning agent.

Yesterday, FDA announced that they had approved a name change for the antidepressant product to Trintellix.  This change hopefully will help avoid medication errors for these products that previously had sound-alike and look-alike names. 

April Approval Actions Steady for FY 2016

The Office of Generic Drugs (OGD) fully approved (AP) 53 ANDAs and issued 16 Tentative Approvals (TAs) in the month of April.  Thus far in FY 2016, OGD approved a total of 399 ANDAs averaging 57 a month-a 29% increase over FY 2015’s average of 41 a month.

Tentative Approvals in FY 2016 total 109 through the first 7 month of the FY,