1. Pink Sheet

Cymbalta for Fibromyalgia: The REMS That Wasn't

 
• By Michael McCaughan

FDA will not necessarily require a formal Risk Evaluation & Mitigation Strategy for drugs that already have mandatory consumer medication guides. That means Lilly has a freer hand to compete against Lyrica in an important new market--and now the question becomes what FDA might do to impose tighter controls on the Pfizer brand.

FDA’s approval of Eli Lilly & Co.’s Cymbalta (duloxetine) for treatment of fibromyalgia sets another precedent in the new era of Risk Evaluation & Mitigation Strategies: the agency will not necessarily seek a formal REMS for products already accompanied by mandatory medication guides.

Cymbalta received FDA approval for the new indication on June 13. Like all antidepressants, duloxetine carries a boxed warning in...

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