The FDA announced that it plans on pulling 249 ANDAs from various holders for failing to file annual reports.
ANDA holders are legally required to submit annual reports on their approved applications. However, the holders of the 249 ANDAs, including Johnson and Johnson and Sandoz, repeatedly failed to file the reports and did not respond to the agency’s requests for them.
The ANDA holders will have the opportunity to request a hearing to show why the applications should not be withdrawn and to raise any other issues relating to the status of the products.
The agency also noted that failure of ANDA holders to submit a timely request for a hearing means that the holder is choosing not to have one and giving up its right to challenge any concerns with the legal status of the product.