CDER News

Comprehensive List of Guidance Documents

New/Revised/Withdrawn List for 2008

Labeling OTC Human Drug Products -- Questions and Answers

Designating Additions to the Current List of Tropical Diseases in the Food and Drug Administration Amendments Act; Public Hearing, 12/12/2008; Presentations

Drug Firm Annual Registration Status updated. The status report now includes Data Universal Numbering System Number.

The U.S. Food and Drug Administration recently approved the injectable drug degarelix, the first new drug in several years for prostate cancer. Degarelix is intended to treat patients with advanced prostate cancer. It belongs to a class of agents called gonadotropin releasing hormone (GnRH) receptor inhibitors.

APP has supplies available and is currently allocating (50 mL vial -NDC 63323-103-51, 100 mL vial -NDC 63323-103-65, and 200 mL - NDC 63323-103-64). Teva has their 50 mL vial (NDC 00703-5747-01) and 100 mL vial (NDC 00703-5748-11) on back order with expected releases in the next several weeks. Bedford has all presentations, including Novaplus presentations, on backorder with no release date.

Nationwide recall of a single lot due to potential for oversized tablets.

Drug Approval Reports

Office of Generic Drugs: List of Authorized Generic Drugs (updated)