Archive - 2010

Sigmapharm files an Abbreviated New Drug Application (ANDA No. 202545).

Sigmapharm files an Abbreviated New Drug Application (ANDA No. 202482).

Gilead Sciences, Inc., sues Sigmapharm Laboratories, LLC, to challenge the approval of Sigmapharm’s Adefovir Dipivoxil Tablets proposed as the generic equivalent of Gilead’s HEPSERA^® Tablets.  

• Sigmapharm launches its 3^rd generic product, Ergocalciferol Capsules, USP 1.25 mg (equivalent to 50,000 USP units of Vitamin D), for commercial marketing through Rising Pharmaceuticals, Inc.


• Sigmapharm receives FDA approval for generic Ergocalciferol Capsules, USP 1.25 mg (equivalent to 50,000 USP units of Vitamin D), based on its ANDA No. 091004.

• Sigmapharm launches, through Rising Pharmaceuticals, Inc., its 2^nd generic product, Protriptyline Hydrochloride Tablets, USP 5 mg and 10 mg, which is the second approved generic equivalent to VIVACTIL^® Tablets.


• Sigmapharm files an Abbreviated New Drug Application (ANDA No. 202051), which contains a Paragraph-IV certification.  This is our 1^st Paragraph-IV filing.


• Sigmapharm files a Drug Master File for Amorphous Adefovir Dipivoxil (DMF No. 023844).  This is our 1^st DMF submission.

Sigmapharm receives FDA approval for generic Protriptyline Hydrochloride Tablets, USP 5 mg and 10 mg, based on its ANDA No. 090462.

Sigmapharm files an Abbreviated New Drug Application (ANDA No. 201566).