Archive - 2018

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

• 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 12^th generic product, Dofetilide Capsules, 0.125 mg, 0.25 mg and 0.5 mg, which is the second approved generic equivalent to TIKOSYN^® Capsules.

• 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.

• 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.

Sigmapharm announces that the expected April-30^th 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.

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.

Sigmapharm announces the discontinuation of its 100-count and 1000-count Liothyronine Sodium product line, becoming effective on April 30, 2018.