Eton Pharmaceuticals Provides Update on the FDA Review of EM-100

Rhea-AI Summary

Eton Pharmaceuticals, Inc. (Nasdaq: ETON) announced that its partner has yet to receive any communication from the FDA regarding the review of EM-100, with a Generic Drug User Fee Act (GDUFA) target action date of September 15, 2020. The company is optimistic about a forthcoming decision and reports no outstanding information requests. Eton focuses on developing innovative drug products, particularly in hospital injectables and pediatric rare diseases, with past successes including Biorphen, an FDA-approved ready-to-use formulation launched in December 2019.

Positive

• No outstanding information requests noted by the FDA, indicating potential readiness for approval.
• Focus on innovative drug development in niche markets such as pediatric rare diseases.

Negative

• Delay in receiving FDA communication regarding EM-100 review could impact timelines.
• Uncertainty regarding FDA's decision may affect investor confidence.

DEER PARK, Ill., Sept. 16, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative drug products, reported that its partner has not yet received a communication from the U.S. Food and Drug Administration (FDA) regarding its decision on the review of EM-100. EM-100’s Generic Drug User Fee Act (GDUFA) target action date was September 15th. The company is not aware of any information requests outstanding and expects the FDA to communicate a decision shortly.

About Eton Pharmaceuticals
Eton Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing, acquiring, and commercializing innovative products. Eton is primarily focused on hospital injectable and pediatric rare disease products. The company’s first commercial product, Biorphen, is the only FDA approved ready-to-use formulation of phenylephrine injection and was launched in December 2019. The company’s lead pediatric product is the orphan drug Alkindi® Sprinkle, which is currently under review with the FDA.

Company Contact:
David Krempa
dkrempa@etonpharma.com
612-387-3740

FAQ

What is the latest update on Eton Pharmaceuticals' EM-100 review by the FDA?

Eton Pharmaceuticals reported that its partner has not yet received any communication from the FDA regarding the review of EM-100, which had a target action date of September 15, 2020.

What does the FDA's Generic Drug User Fee Act target action date mean for Eton?

The GDUFA target action date is a deadline for the FDA to make a decision on a generic drug application. Eton's EM-100 was due for review by this date.

What is Eton Pharmaceuticals' primary focus in drug development?

Eton Pharmaceuticals specializes in developing innovative drug products, particularly targeting hospital injectables and pediatric rare diseases.

How has Eton Pharmaceuticals performed in recent product launches?

Eton's first commercial product, Biorphen, was successfully launched in December 2019 as the only FDA-approved ready-to-use formulation of phenylephrine injection.