NexMed, Inc., a specialty CRO with a pipeline of product candidates based on the NexACT technology, announced that Health Canada has confirmed acceptance of the company’s CMC (Chemistry, Manufacturing and Controls) response for review. The Screening Acceptance Letter (the Acceptance Letter) from Health Canada was issued in connection with its New Drug Submission (NDS) for Vitaros, the company’s topical treatment for erectile dysfunction.
The Acceptance Letter confirms that the CMC response filed by NexMed is acceptable for the final, 150-day review cycle, during which regulatory reviewers will determine the final approvability of the product for marketing in Canada. Based on the date of acceptance, a final approval decision is expected by the end of November 2010.
Commenting on the news, Bassam Damaj, Ph.D., president and chief executive officer of NexMed, stated, “Receipt of the Acceptance Letter marks another important milestone in the development history of Vitaros and we remain positive about the possibility for eventual product approval. As such, we anticipate utilizing our Canadian application as the basis for filing new marketing applications in other international markets.”
NexMed is the largest specialty CRO based in San Diego, CA and is one of the industry's most experienced CROs for in vitro and in vivo pharmacology services and research models.