• 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.

  • September 2015

    Sigmapharm launches its 11th generic product, Acitretin Capsules, USP 10 mg, 17.5 mg and 25 mg, exclusively under its own label.

  • July 2015
    • Sigmapharm files an Abbreviated New Drug Application (ANDA No. 208596) which includes a Paragraph-IV certification (our 7th Paragraph-IV filing).

    • Sigmapharm files an Abbreviated New Drug Application (ANDA No. 208546) which includes a Paragraph-IV certification (our 6th Paragraph-IV filing).

  • June 2015
    • Gilead Sciences, Inc., sues Sigmapharm Laboratories, LLC, to challenge the approval of Sigmapharm’s Ambrisentan Tablets proposed as the generic equivalent of Gilead’s LETAIRIS® Tablets.  

    • Sigmapharm successfully completes an FDA inspection focused on the company’s reporting of its Post-marketing Adverse Drug Experience.

  • May 2015

    Sigmapharm receives FDA approval for generic Acitretin Capsules, USP 10 mg, 17.5 mg, 22.5 mg and 25 mg, based on its ANDA No. 204633.