To provide an affordable gout flare prevention option to patients, West-Ward (now known as Hikma Pharmaceuticals USA) secured FDA approval for Mitigare® (colchicine) via the 505(b)(2) pathway.
- A 505(b)(2) application is a New Drug Application that contains full reports of safety and efficacy data. However, some of the data is from studies not conducted by or for the applicant.
- Medications approved under section 505(b)(2) are considered safe and effective for their improved indications.
- Many drugs have been approved via the 505(b)(2) pathway, including Colcrys®.
Commitment to affordable gout flare prevention
West-Ward Pharmaceuticals brought Mitigare® to market to offer patients an affordable treatment option for gout flare prevention.
- Since the launch of Mitigare® in 2014, the price of Colcrys® has increased by a total of 24.4 percent.
- Hikma Pharmaceuticals USA continues to offer the lowest-priced brand name and authorized generic colchicine 0.6 mg capsules for adult gout flare prevention.