• March 2018

    Sigmapharm receives FDA approval for generic Dofetilide Capsules, 0.125 mg, 0.25 mg and 0.5 mg, based on its ANDA No. 207746 containing a Paragraph-IV certification.

  • January 2018

    Sigmapharm announces the discontinuation of its 100-count and 1000-count Liothyronine Sodium product line, becoming effective on April 30, 2018.

  • September 2017

    Sigmapharm files an Abbreviated New Drug Application (ANDA No. 211084) which includes a paragraph-IV certification (our 9th Paragraph-IV filing).

  • August 2017

    Sigmapharm files a Drug Master File for Amorphous Vortioxetine Hydrobromide (Type II DMF No. 031898). 

  • June 2017

    Sigmapharm successfully completes an FDA inspection focused on its current GMP status.

  • 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.  

  • December 2016

    Sigmapharm files an Abbreviated New Drug Application (ANDA No. 210053) which includes a Paragraph-IV certification (our 8th Paragraph-IV filing).

  • August 2016
    • Sigmapharm receives FDA approval for generic Potassium Chloride Extended-Release Tablets, USP 8 mEq (600 mg) and 10 mEq (750 mg), based on its ANDA No. 207528.

    • Sigmapharm files a Drug Master File for Amorphous Apixaban (Type II DMF No. 030774).

  • January 2016

    Sigmapharm successfully completes an FDA inspection focused on a Pre-Approval-Inspection related to its ANDA No. 207528.

  • October 2015
    • Janssen Pharmaceuticals, Inc., sues Sigmapharm Laboratories, LLC, to challenge the approval of Sigmapharm’s Rivaroxaban Tablets proposed as the generic equivalent of Janssen’s XARELTO® Tablets. 

    • AstraZeneca Pharmaceuticals, LP, sues Sigmapharm Laboratories, LLC, to challenge the approval of Sigmapharm’s Ticagrelor Tablets proposed as the generic equivalent of AstraZeneca’s BRILINTA® Tablets.