Sigmapharm relaunches its generic Griseofulvin Tablets, USP (microsize) 500 mg, exclusively under its own label.
Sigmapharm files an Abbreviated New Drug Application (ANDA No. 213896) which is designated by the FDA as a Competitive Generics Therapy (CGT) product.
Sigmapharm launches its generic Ambrisentan Tablets, 5mg and 10mg.
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.
Sigmapharm receives FDA approval for generic Ambrisentan Tablets, 5 mg and 10 mg, based on its ANDA No. 208354 containing a Paragraph IV certification.
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 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.
- 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-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.