NexMed Updates on Canadian Approval Process for Vitaros

SAN DIEGO--(BUSINESS WIRE)--NexMed, Inc. (Nasdaq: NEXM), a specialty CRO and a developer of products based on the NexACT® technology, announced today that it received a Notice of Non-Compliance (“Notice”) as part of the review process from Health Canada for its New Drug Submission (“NDS”) for the Vitaros erectile dysfunction treatment filed in February 2008. The deficiencies cited related to the product’s CMC (Chemistry, Manufacturing and Controls). There were no pre-clinical or clinical deficiencies cited in the Notice. The Notice is a routine end-of-review communication from Health Canada when additional information is needed to reach final decision on product approval.

MORE ON THIS TOPIC