• May 2019

    Dr. Spireas, the Founder, Chairman and Chief Executive Officer of Sigmapharm Laboratories, received today (May 14, 2019) an Honorary Doctor of Science (D.Sc.) degree from Long Island University, Brooklyn, New York.

  • April 2019

    Sigmapharm receives FDA approval for generic Ambrisentan Tablets, 5 mg and 10 mg, based on its ANDA No. 208354 containing a Paragraph IV certification.

  • October 2018

    Sigmapharm successfully completes an FDA inspection focused on its current GMP status and a Pre-Approval-Inspection related to its ANDA No. 211084.

  • July 2018
    • Sigmapharm receives FDA approval for generic Asenapine Sublingual Tablets, 5 mg and 10 mg, based on its ANDA No. 206107 containing a First-to-File Paragraph-IV certification.

    • Sigmapharm launches, exclusively under its own label, its 12th generic product, Dofetilide Capsules, 0.125 mg, 0.25 mg and 0.5 mg, which is the second approved generic equivalent to TIKOSYN® Capsules.

  • June 2018
    • Sigmapharm successfully completes an FDA inspection focused on the company’s reporting of its Post-marketing Adverse Drug Experience.

    • Sigmapharm relaunches its generic Flucytosine Capsules, USP 250 mg and 500 mg, exclusively under its own label.

  • May 2018
    • Sigmapharm receives FDA approval for generic Nitroglycerin Sublingual Tablets, USP 0.3 mg, 0.4 mg and 0.6 mg, based on its ANDA No. 207745 containing a First-to-File Paragraph-IV certification.

    • Takeda Pharmaceuticals USA, Inc., sues Sigmapharm Laboratories, LLC, to challenge the approval of Sigmapharm’s Vortioxetine Hydrobromide Tablets proposed as the generic equivalent of Takeda’s TRINTELLIX® Tablets.

    • Sigmapharm launches, exclusively under its own label, its generic Liothyronine Sodium Tablets, USP 5 mcg, 25 mcg and 50 mcg, packaged in 90-count bottles.

  • April 2018

    Sigmapharm announces that the expected April-30th discontinuation of its current Liothyronine Sodium product line will be immediately followed, on May 1, 2018, by the launch of a replacement product line packaged in 90-count bottles only.

  • 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).