Following notice given in December 2004 that the FDA would not approve the product for release after the company’s first submission, Cellegy has provided a written response containing new analyses of data from its three Cellegesic phase III trials.
The FDA has indicated that under the agency’s procedural rules, Cellegy’s reply is being viewed as a “complete, Class 1” response to their initial rejection letter. A “Class 1 resubmission” is a resubmission that includes a minor re-analysis of data previously submitted to the application.
Cellegesic (0.4% nitroglycerin ointment), is already approved outside the US under the name Rectogesic for the treatment of pain associated with chronic anal fissures. Launch of Rectogesic in the UK is expected in the first half of 2005. A similar formulation of Rectogesic is currently being sold in Australia, New Zealand, Singapore and South Korea.