Lovenox Lawsuit May Be Omen For Biosimilar Battles
Sanofi-Aventis' suit against FDA seeking to overturn its approval of generic Lovenox (enoxaparin) is a harbinger of what the agency will face once it approves follow-on biologics
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U.S. Congressional Investigation Of Tainted Heparin Could Highlight Need For Import Safety Legislation - Or Not
A U.S. House of Representatives Energy and Commerce Committee investigation into who caused contamination of heparin supplies in 2007 and 2008, how it was done, and U.S. FDA's handling of the crisis, could revive interest in legislation designed to strengthen FDA's oversight of drugs and other medical products entering the U.S. from overseas
Energy and Commerce Republicans seek to determine who contaminated heparin supplies in 2008, how they did it, and why FDA has failed to answer those questions as the panel begins oversight of the agency.
Amphastar’s initial lawsuit against FDA achieved its stated goal: the agency released two shipments of raw heparin material the company is to use in producing generic Lovenox (enoxaparin).