Biotech Values

[investorgold2002]

http://www.pharmacytimes.com/publications/issue/2008/2008-01/2008-01-8332

The agency's efforts to bring cost-saving generic drugs to pharmacy shelves is already paying off, with generic-product approvals climbing 30% in fiscal year 2007 to a record 682 drugs. To boost that approval rate even faster, the GIVE initiative empowers the FDA to revise the review order for certain drug applications to place extra emphasis on generics expected to have substantial market impact.

As an example, FDA Generic Drug Director Gary Buehler explained that "first generic products," for which there are no blocking patents or exclusivity protections on the reference listed drug, will be earmarked by the agency for expedited review."This will mean that these products, for which there are currently no generic products on the market, may reach the consumer much faster," agency officials said.

Copaxone fails from patent perspective...2014 is patent expiry