Archive - 2014

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

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.

• 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 4^th Paragraph-IV filing).


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

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

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