28 November, 2018 14:53 CET
EGeen International Clinical Trial Services Result in Akorn ANDA Approval
MOUNTAIN VIEW, CA. – Following a successful clinical trial executed by EGeen International, Inc., its’ client, Akorn, Inc. (Nasdaq: AKRX), a leading specialty generic pharmaceutical company, recently received a new Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration for diclofenac sodium topical gel, 1%.
Diclofenac sodium topical gel, 1% is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knee and hand joints. Diclofenac sodium topical gel, 1% has not been evaluated for use on the spine, hip, or shoulder.
EGeen’s trial result was notable as one of the first clinical trial successes in bringing a generic diclofenac product to the market using the WOMAC pain scale clinical endpoint study. The trial was completed under timeline and within the project budget.
EGeen International, Inc. is known for its’ Generic Drug Development (GDD) Program, leveraging the cost effective European trial environment to support worldwide filings and approvals of generic pharmaceutical products.
Akorn, Inc. is a specialty generic pharmaceutical company engaged in the development, manufacture and marketing of multisource and branded pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois; Somerset, New Jersey; Amityville, New York; Hettlingen, Switzerland and Paonta Sahib, India that manufacture ophthalmic, injectable and specialty sterile and non-sterile pharmaceuticals. Additional information is available on Akorn’s website at www.akorn.com.