Sunovion gets CRL for Parkinson’s drug

Feb 04, 2019

Sunovion Pharma announced that the U.S. FDA issued a Complete Response Letter for the New Drug Application for the drugmaker's apomorphine sublingual film to treat OFF episodes experienced by people living with Parkinson’s disease.

Upon review of the application, the FDA determined that it was unable to approve the Massachusetts-based drugmaker's NDA without additional information and analyses, but did not ask for new clinical trials.

The new drug was expected to compete against Acorda Therapeutics' drug, Inbrija, which won FDA approval in December.

Sunovion says it remains committed to working with the agency to address its requests.

Read the press release

Don't miss your Daily Dose.  Subscribe to our eNewsletter here!

Show Comments
Hide Comments

Join the discussion

We welcome your thoughtful comments.
All comments will display your user name.

Want to participate in the discussion?

Register for free

Log in for complete access.


No one has commented on this page yet.

RSS feed for comments on this page | RSS feed for all comments