Natco on Thursday alleged that Teva is trying to delay the abbreviated new drug application (ANDA) approval for Natco and Mylan’s glatiramer acetate. To that end, the Israeli drug maker had filed a citizen petition with the US Food and Drug Administration.

On November 24, Financial Chronicle had reported that Teva had moved the FDA on grounds that Natco’s glatiramer process is devoid of adequate controls. The Natco spokesperson was not available for comment when FC was filing its first report.

In an official communiqué on Thursday, Natco, while admitting that Teva had filed a citizen petition with FDA, said, “It is part of its effort to prolong its monopoly on Copaxone, used in the treatment of multiple sclerosis in the US. The citizen petition is similar to another petition that Teva had filed in 2008, which was rejected by FDA earlier this year. Natco would like to state that filing of a citizen petition is a common tactic employed by branded pharma companies in the US to delay generic competition and Teva seems to have borrowed this idea. Natco stands firmly behind the safety and integrity of glatiramer acetate products and Natco intends to suitably respond to Teva’s unfounded claims.”

It may be recalled that last year, Natco had entered into a license and supply agreement with Mylan, which granted Mylan exclusive distribution rights for glatiramer acetate prefilled syringes in the US.