|
FDA Seeks Manufacturing Details in Complete Response to Watson
Watson Pharmaceuticals has been asked by the FDA for more information on manufacturing and clinical testing of its long-acting form of the Trelstar prostate cancer treatment.
The agency’s complete response letter referenced the chemistry, manufacturing and controls (CMC) of the product and third-party manufacturing, Watson says in a statement last month.
Watson has responded to many of the questions raised about Trelstar’s (triptorelin pamoate) CMC but declined to give additional details on the FDA’s concerns or its response, company spokeswoman Patty Eisenhaur said. |
|
Register Now
Archives