[Pharm-policy] Melody Peterson: generic Buspirone approval

[love@cptech.org]

There has been a major battle over generic approval of Buspirone, and
according to this NYT account, Mylan has won an important court victory
over BMS.  The dispute involves an important evergreening strategy by
BMS, to extend their monopoly beyond the term of the initial patent on
the product.  Jamie

http://www.nytimes.com/2001/03/14/business/14DRUG.html

March 14, 2001 
Judge Says Mylan Can Sell Generic Version of Bristol-Myers Drug
By MELODY PETERSEN

A federal judge ruled yesterday that Bristol-Myers Squibb had harmed the
public interest late last year when it used a loophole in a federal law
to stop a generic drug company from selling a low-cost version of a
popular anti-anxiety drug.

The judge, Ricardo M. Urbina of the United States District Court for the
District of Columbia, ordered the Food and Drug Administration to
immediately approve the request of Mylan Laboratories Inc. to sell a
generic version of the drug, buspirone, sold under the trade name
BuSpar. The drug is often used in nursing homes.

  [snip]