Archive - 2013

Sigmapharm launches, exclusively under its own label, its 10^th generic product, Adefovir Dipivoxil Tablets, 10 mg, which is the first-and-only approved generic equivalent to Gilead’s HEPSERA^® Tablets.

• Sigmapharm receives FDA approval for generic Adefovir Dipivoxil Tablets, 10 mg, based on its ANDA No. 202051 containing a First-to-File Paragraph-IV certification.


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


• Sigmapharm files a Drug Master File for Amorphous Asenapine Maleate (DMF No. 027300). 


• Sigmapharm files an Abbreviated New Drug Application (ANDA No. 206107) which includes a Paragraph-IV certification (our 2^nd Paragraph-IV filing).

Sigmapharm files an Abbreviated New Drug Application (ANDA No. 205569).

• Sigmapharm launches, exclusively under its own label, its 9^th generic product, Sodium Phenylbutyrate Powder in 250-g-fill Bottles, which is the first-and-only approved generic equivalent to BUPHENYL^® Powder.


• Sigmapharm receives FDA approval for generic Sodium Phenylbutyrate Powder in 250-g-fill Bottles, based on its ANDA No. 202819.