• 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.

  • April 2015

    Sigmapharm files an Abbreviated New Drug Application (ANDA No. 208354) which includes a Paragraph-IV certification (our 5th Paragraph-IV filing).

  • November 2014

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

  • September 2014

    Forest Laboratories, LLC, sues Sigmapharm Laboratories, LLC, to challenge the approval of Sigmapharm’s Asenapine Sublingual Tablets proposed as the generic equivalent of Forest’s SAPHRIS® Sublingual Tablets.

  • June 2014
    • Sigmapharm files an Abbreviated New Drug Application (ANDA No. 207744).

    • Sigmapharm files an Abbreviated New Drug Application (ANDA No. 207745) which includes a Paragraph-IV certification (our 4th Paragraph-IV filing).

    • Sigmapharm files an Abbreviated New Drug Application (ANDA No. 207746) which includes a Paragraph-IV certification (our 3rd Paragraph-IV filing).

    • Sigmapharm files an Abbreviated New Drug Application (ANDA No. 207528).

    • Sigmapharm files a Drug Master File for Amorphous Dofetilide (DMF No. 028301).

  • April 2014

    Sigmapharm voluntarily conducts a recall for 4 lots of its Liothyronine Sodium Tablets, USP 5 mcg, 100-count and 1000-count.  

  • March 2014

    Sigmapharm completes an FDA inspection focused on its current GMP status and a Pre-Approval-Inspection related to its ANDA No. 205569.

  • September 2013

    Sigmapharm launches, exclusively under its own label, its 10th generic product, Adefovir Dipivoxil Tablets, 10 mg, which is the first-and-only approved generic equivalent to Gilead’s HEPSERA® Tablets.

  • August 2013
    • Sigmapharm receives FDA approval for generic Adefovir Dipivoxil Tablets, 10 mg, based on its ANDA No. 202051 containing a First-to-File Paragraph-IV certification.

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

    • Sigmapharm files a Drug Master File for Amorphous Asenapine Maleate (DMF No. 027300). 

    • Sigmapharm files an Abbreviated New Drug Application (ANDA No. 206107) which includes a Paragraph-IV certification (our 2nd Paragraph-IV filing).

  • April 2013

    Sigmapharm files an Abbreviated New Drug Application (ANDA No. 205569).