FDA Delays OPKO Drug Approval Due to Catalent Inspection Issues

April 1, 2016

The U.S. FDA has issued a complete response letter (CRL) to OPKO Health's New Drug Application for Rayaldee.

Normally, the FDA issues complete response letters to drug companies to communicate the decision that an NDA or ANDA will not be approved in its present form. However, in this case, the letter was based entirely on deficiencies observed at Catalent -- the CMO enlisted to manufacture Rayaldee.

The FDA noted that observations of deficiencies at Catalent's Florida facility were issued on March 25, 2016 as a result of an FDA field inspection initiated on March 14, 2016

OPKO is seeking approval for Rayaldee as a treatment for secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease and vitamin D insufficiency.

Read the OPKO press release