Preapproval Actions For Generic Drugs Are Also Preempted, Judge Rules

Mealey's (January 19, 2016, 4:20 PM EST) -- MIAMI — A Florida federal judge on Jan. 7 rejected a plaintiff’s attempt to get around generic drug preemption by making claims about what the company should have done before getting federal approval for a generic hormone replacement therapy drug (Maggie Tsavaris v. Pfizer, Inc., et al., No. 15-21826, S.D. Fla.; 2016 U.S. Dist. LEXIS 1680).

(Tsavaris opinion available. Document #28-160121-007Z.)

In January 2005, Maggie Tsavaris was prescribed Prempro to treat menopause symptoms and took it less than continually until July 2005. In September 2008, Tsavaris...
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