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NEW YORK, Mar 28 (Reuters Health) - The US Food and Drug Administration (FDA) has approved a needle-free device for the delivery of Serostim (somatropin for injection), a drug for treating people with AIDS developed by Swiss biotech firm Serono, the company said on Wednesday.
The drug treats wasting, a severe loss of muscle mass that occurs in some people with AIDS.
Developed with Norwell, MA-based Bioject, the device, called SeroJet, delivers Serostim under the skin in a fine, pressurized stream. While proven to be bioequivalent to needle injections, the SeroJet helps to reduce the risk of needle-stick injuries, the companies said.
Serono said it plans to launch the product in the second half of 2000, following the anticipated receipt of FDA approval to expand the dose volume options for Serostim.
Serostim was approved by US regulators in 1996.
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