Posted from: Monday, October 08, 2018 - 12:43 PM - Present

Ampyra Generic Launched

September 21, 2018 – Mylan has launched its authorized generic for Acorda Therapeutics’ Ampyra® (dalfampridine). Dalfampridine is U.S. FDA approved to improve walking, demonstrated by an increase in walking speed, in patients who have multiple sclerosis (MS).

An estimated 1 million individuals in the United States have MS, a central nervous system (CNS) disorder caused when the body’s immune system attacks protective myelin sheaths that cover nerve fibers. When these sheaths are damaged, it causes a breakdown in the body’s ability to communicate signals through the nerves. This can lead to numbness, weakness, fatigue, loss or doubling of vision, an unsteady gait, and other difficulties.

First FDA approved in 2010, dalfampridine has a maximum recommended dose of 10mg taken twice daily. Higher doses are associated with a higher frequency of adverse effects, including seizures, with no clinical evidence of providing a greater benefit. Dalfampridine may not be appropriate for patients who have renal impairment, due to a greater risk of seizures.

IQVIA reports that U.S. sales for Ampyra reached an estimated $553 million during the 12-month period ending on June 30, 2018. Mylan’s generic is one of several approved by the FDA, though other manufacturers have yet to provide launch information for their products. It is available at a wholesale acquisition cost of $2,323.19 per month.

 

Last Updated Friday, October 19, 2018 - 03:08 PM.