Miami-based Noven Pharmaceuticals said the FDA has rejected its generic version of a Duragesic pain patch, saying that higher concentrations of the drug might make it less safe. Noven and its partner, Endo, met with regulators yesterday. The FDA announced in July that it was investigating reported deaths and side effects linked to the Durgesic patch and other copycats on the market. Noven said it disagreed with the FDA's conclusion and would study how it might obtain approval for the product.
- read this AP story [1] for more
Links:
[1] http://www.businessweek.com/ap/financialnews/D8CT8KIG2.htm?campaign_id=apn_home_down&chan=db