Recent
Developments in Generics
Last updated March 2, 2010. For more information
contact Ed Thwaite.
- Authorized Generic information must once again be submitted by the brand company to the FDA in their annual report, reversing a "hold" on this plan.
- FDA'sFDA's Janet Woodcock was cleared of "conflict" relating to the Lovenox generic reviews. It was asserted that she had "favored" Momenta.
- GPhA is upset with the Obama Healthcare Bill, as it would ban settlements between generic and brand companies when a patent challenge is involved.
- Perrigo had a major victory - a Michigan court said their product does not infringe the patent of Mucinex.
- Ranbaxy's FDA problems still continue. Now the FDA wants Ranbaxy to review all global manufacturing sites that make products that are shipped to the US.
- Solvay's deal with Par, Watson, and Paddock, which may have delayed generics of AndroGel, was deemed legal in an Atlanta district Court.
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