Long Grove gets FDA OK for generic Radicava
Long Grove Pharmaceuticals has received the Food and Drug Administration's approval for generic edaravone injection, which is a generic of Radicava IV.
It is used to treat amyotrophic lateral sclerosis. The FDA approved Radicava in 2017, making it the first new treatment for ALS in more than 20 years. Edaravone targets and helps remove free radicals to reduce nerve damage and slow the progression of ALS, a neurodegenerative disease.
“Currently, a generic equivalent for Edaravone Injection is not commercially available,” said Peter Karas, chief commercial officer of Long Grove Pharmaceuticals. “A generic increases the number of patients who can benefit from this critical ALS treatment option, and we’re grateful for the opportunity to help expand access.”
[Read more: Long Grove partners with Sunny Pharmtech to launch cyclophosphamide for injection]
The company’s edaravone injection comes in a ready-to-use premix formulation with two 30 mg/100 ml bags per carton. The formulation is stable at room temperature and the IV bags are not made with natural rubber latex, DEHP or PVC, the company said.
[Read more: Long Grove to market norepinephrine in sodium chloride premix injection]