Equidyne Corp. Receives FDA Approval for OTC Marketing of the INJEX 30 System for Insulin
Thursday September 12, 9:05 am ET
SAN DIEGO--(BUSINESS WIRE)--Sept. 12, 2002--Equidyne Corp. (AMEX:IJX - News) announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) to market the needle-free INJEX 30 System "over the counter" for insulin administration.
Commenting on the new 510(k) approval, Marcus Rowan, chief executive officer, stated, "We are pleased with the FDA's decision to grant OTC approval for INJEX 30 System for insulin administration. This approval represents a further affirmation of the safety and ease of use of the INJEX 30 System."
OTC marketing of the INJEX 30 System will require specific product and packaging labeling changes to differentiate the OTC version from the currently marketed INJEX 30 System requiring a physician's prescription. At this time the company does not plan to initiate over-the-counter sales prior to development of a strategic partnership or licensing arrangement to facilitate OTC sales of the product.
About the Company:
Equidyne Corp. (www.equidyne.com), through Equidyne Systems Inc., its wholly-owned subsidiary based in San Diego, is working to capitalize on the growing market for needle-free drug delivery systems for subcutaneous injections. The INJEX needle-free injector is a compact, uncomplicated device that delivers a virtually painless injection through the skin in a fraction of a second, and eliminates needle stick and disposal problems. The INJEX System is a comfortable, economical alternative to delivering medications using conventional needle injections.
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