Office of Combination Products or new drug approval?

A question for those who know more than me. Why is Acrux presenting its new product development pipeline as if it has to go through all the stages of new drug approval, which of course takes many years? But the drugs mentioned are well-known and approved long since (ibuprofen, diclofenac), so why is the process not an application to the Office of Combination Products, which surely must take far less time than indicated by Acrux?

In 2009, the FDA wrote that ' the median approval time for standard applications was 17.6 months in FY 1998, decreased to 12.0 months in FY 1999, increased to 14.6 months in FY 2000, increased to 22.1 months in FY 2001, and dropped to 12.8 months in FY 2002. In FY 2003, the estimated median approval time for standard applications increased slightly to 13.0 months and in FY 2004 was estimated to decrease to 10.5 months.'  (http://www.fda.gov/aboutfda/reports...erfeereports/performancereports/ucm134613.htm)