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Tag Archives: FDA approvals

Producers of Generic Medicines and Biosimilars even More Supported by EU

Producers of Generic Medicines and Biosimilars even More Supported by EU

  Effective 1 July 2019, the EU adopted a regulation by introducing a supplementary protection certificate (SPC) manufacturing and stockpiling waiver. This waiver also applies for biosimilar versions of SPC-protected medicine during the term of the SPC. SPC’s are defined as IP rights extending patent protection for up to five years for medicines that are […]

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FDA Approves First Generic of Popular Blood Thinner

FDA Approves First Generic of Popular Blood Thinner

The first generic versions of the powerful blood thinner Eliquis (apixaban) were approved by the U.S. Food and Drug Administration on Monday. “Today’s approvals of the first generics of apixaban are an example of how the FDA’s generic drug program improves access to lower-cost, safe and high-quality medicines,” Dr. Janet Woodcock, director of the FDA’s […]

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