Vanda Pharmaceuticals (VNDA) said in a filing Monday that the US Food and Drug Administration's planned review timelines of its new drug application for tradipitant, a motion sickness treatment, goes against the Food Drug and Cosmetic Act.

The regulator has set a target decision date of Dec. 30, which is 12 months after the application was submitted and six months later than the statutory deadline, the company added.

Vanda called the FDA "broken" and "unaccountable" for taking longer than expected to review the drug, despite two large clinical studies with 681 participants showing positive results. The trials showed that tradipitant significantly reduced motion-induced vomiting compared to a placebo, the company said.

Vanda Pharmaceuticals shares were 2% up in recent trading activity.

Price: 5.08, Change: +0.10, Percent Change: +2.01