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.
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.
Sigmapharm files an Abbreviated New Drug Application (ANDA No. 211084) which includes a paragraph-IV certification (our 9th Paragraph-IV filing).
Sigmapharm files a Drug Master File for Amorphous Vortioxetine Hydrobromide (Type II DMF No. 031898).
Sigmapharm successfully completes an FDA inspection focused on its current GMP status.
Bristol Myers Squibb Company and Pfizer, Inc., sue Sigmapharm Laboratories, LLC, to challenge the approval of Sigmapharm’s Apixaban Tablets proposed as the generic equivalent of BMS-Pfizer’s ELIQUIS® Tablets.
Sigmapharm files an Abbreviated New Drug Application (ANDA No. 210053) which includes a Paragraph-IV certification (our 8th Paragraph-IV filing).
- Sigmapharm receives FDA approval for generic Potassium Chloride Extended-Release Tablets, USP 8 mEq (600 mg) and 10 mEq (750 mg), based on its ANDA No. 207528.
- Sigmapharm files a Drug Master File for Amorphous Apixaban (Type II DMF No. 030774).
Sigmapharm successfully completes an FDA inspection focused on a Pre-Approval-Inspection related to its ANDA No. 207528.