TC Home

The only technical publication dedicated to readers who formulate, manufacture, or package solid dosage forms.

Slide background
Slide background
  • February 28, 2019

SILVER SPRING, MD—The FDA published a draft guidance for industry “ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs,” which provides recommendations for applicants preparing and submitting amendments to tentatively approved abbreviated new drug applications (ANDAs), including requests for final approval. This guidance also features tips for the timing and content of amendments to tentatively approved ANDAs to facilitate submission in a timely fashion that can result in final approval on the earliest lawful approval date.
In other news, the agency granted 59 drug approvals in 2018. This exceeds the 2017 record of 46 novel drug approvals, which at the time had been the most approved in a single year in two decades.