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Eton Pharmaceuticals seeks US FDA approval of injectable hospital-use drug

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Eton Pharmaceuticals seeks US FDA approval of injectable hospital-use drug

Eton Pharmaceuticals Inc. submitted an application to the U.S. Food and Drug Administration seeking approval of its experimental, injectable hospital-use product DS-200.

The Deer Park, Ill.-based specialty pharmaceutical company, which launched an IPO in 2018, made a submission under the FDA's rolling review process. Under rolling review, companies can submit completed sections of its new drug application rather than wait for every section of the application to be completed before submission.

DS-200, which has received a fast-track designation from the FDA, is an injectable parenteral nutrition product.

Eton said there are no approved versions of DS-200's molecule in injectable form, but its active ingredient is being supplied in the U.S. market through an unapproved drug product.

The company noted that if DS-200 is approved, the unapproved product will have to exit the market within 12 months, according to FDA guidelines.

Eton CEO Sean Brynjelsen said the company will work with FDA during the review process and simultaneously plan a potential commercial launch of the product.