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September 2017
Sigmapharm files an Abbreviated New Drug Application (ANDA No. 211084) which includes a paragraph-IV certification (our 9th Paragraph-IV filing).
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August 2017
Sigmapharm files a Drug Master File for Amorphous Vortioxetine Hydrobromide (Type II DMF No. 031898).
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June 2017
Sigmapharm successfully completes an FDA inspection focused on its current GMP status.
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April 2017
Bristol Myers Squibb Company and Pfizer, Inc., sue Sigmapharm Laboratories, LLC, to challenge the approval of Sigmapharm’s Apixaban Tablets proposed as the generic equivalent of BMS-Pfizer’s ELIQUIS® Tablets.
