Antares files 510(k) for needle-free hormone growth injection

By Elaine Rigoli

Tampa, Fla., Aug. 9 - Antares Pharma, Inc. has submitted a 510(k) premarket notification application to the Food and Drug Administration announcing its intent to market a needle-free injection system for use with a branded human growth hormone that is approved and marketed in the United States.

Human growth hormone is an injectable protein that is commonly used to treat children of pathologically short stature, the company said in a news release.

Pediatric patients and their parents, who sometimes assist with the injections, can benefit from the elimination of needles and disposal of contaminated sharps, ease of using alternative injection sites and the speed and quality of injections offered by needle-free devices, the release said.

Antares Pharma is a specialized pharmaceutical product-development company with headquarters in Ewing, N.J.

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