• 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).

  • 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.