Company

Product

Description

Indication

Status

Mezzion Pharma Co. Ltd., of Seoul, South Korea

Udenafil

PDE5 inhibitor

Single ventricle congenital heart disease with Fontan physiology

Conducted type C meeting with U.S. FDA and is taking necessary steps to prepare and submit NDA based on results of Fuel phase III trial

Neuren Pharmaceuticals Ltd., of Melbourne, Australia

NNZ-2591

Synthetic analogue of molecule derived from IGF-1

Angelman syndrome

FDA granted orphan designation

Pfenex Inc., of San Diego

PF-708

Teriparatide injection

Osteoporosis

Partner Alvogen Inc. said marketing authorization application was submitted to the Kingdom of Saudi Arabia's Saudi Food and Drug Authority

Notes

For more information about individual companies and/or products, see Cortellis.

 

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