Gilead receives Notice Letter of Sigmapharm's ANDA submission for generic Hepsera

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Gilead receives Notice Letter of Sigmapharm's ANDA submission for generic Hepsera

Gilead Sciences, Inc. today announced receipt of a Paragraph IV Certification Notice Letter advising that Sigmapharm Laboratories, LLC submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of Hepsera® (adefovir dipivoxil).

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Tags: Hepatitis B Medication, Drug, FDA, Hepsera, Gilead Sciences