Archive - 2015

• Janssen Pharmaceuticals, Inc., sues Sigmapharm Laboratories, LLC, to challenge the approval of Sigmapharm’s Rivaroxaban Tablets proposed as the generic equivalent of Janssen’s XARELTO^® Tablets. 


• AstraZeneca Pharmaceuticals, LP, sues Sigmapharm Laboratories, LLC, to challenge the approval of Sigmapharm’s Ticagrelor Tablets proposed as the generic equivalent of AstraZeneca’s BRILINTA^® Tablets.

Sigmapharm launches its 11^th generic product, Acitretin Capsules, USP 10 mg, 17.5 mg and 25 mg, exclusively under its own label.

• Sigmapharm files an Abbreviated New Drug Application (ANDA No. 208596) which includes a Paragraph-IV certification (our 7^th Paragraph-IV filing).


• Sigmapharm files an Abbreviated New Drug Application (ANDA No. 208546) which includes a Paragraph-IV certification (our 6^th Paragraph-IV filing).

• Gilead Sciences, Inc., sues Sigmapharm Laboratories, LLC, to challenge the approval of Sigmapharm’s Ambrisentan Tablets proposed as the generic equivalent of Gilead’s LETAIRIS^® Tablets.  


• Sigmapharm successfully completes an FDA inspection focused on the company’s reporting of its Post-marketing Adverse Drug Experience.

Sigmapharm receives FDA approval for generic Acitretin Capsules, USP 10 mg, 17.5 mg, 22.5 mg and 25 mg, based on its ANDA No. 204633.

Sigmapharm files an Abbreviated New Drug Application (ANDA No. 208354) which includes a Paragraph-IV certification (our 5^th Paragraph-IV filing).