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Akorn receives lyophilized product approval for IC-Green
LAKE FOREST, Ill. — Akorn's supplemental new drug application for IC-Green for injection has been approved by the U.S. Food and Drug Administration, the company announced in a press release.
IC-Green is the first lyophilized product approved for manufacture in Akorn's Decatur, Ill., production facility, the release said.
To date, Akorn has invested approximately $23 million in a new liquid and lyophilized injectable manufacturing fill line at the facility. Last year, Akorn announced successful results of an FDA pre-approval inspection, which allowed the company to receive lyophilized product approvals in Decatur.
"We intend to commercialize our lyophilization manufacturing capabilities by developing an internal ANDA injectable product line and by expanding our contract pharmaceutical manufacturing business segment to include lyophilized injectable products," Arthur S. Przybyl, Akorn's president and chief executive officer, said in the release.