LAKE FOREST, Ill. -- TAP Pharmaceutical Products Inc. announced today that LuproLoc(TM) is now available for use with Lupron Depot (leuprolide acetate for depot suspension) as the first product in its class to offer a needle safety device on pre-filled syringes. LuproLoc, which has been approved by the U.S. Food and Drug Administration (FDA), features an innovative, integrated safety mechanism attached to pre-filled syringes containing Lupron Depot. The new product is designed to offer healthcare workers additional protection from needlestick injury. Needlestick injury is a cause of occupational exposure to diseases such as HIV, hepatitis B and hepatitis C.
"TAP is not only committed to delivering life-enhancing products to people who need them, but also to helping protect the safety of the healthcare worker," said Tom Watkins, president of TAP. "The safety device in LuproLoc combines excellent functionality and a unique design in an effort to further enhance safety for healthcare workers administering Lupron Depot."
The FDA approval is the result of filings with both the FDA's Center for Drug Evaluation and Research (CDER) and its Center for Devices and Radiological Health (CDRH). The device is the first product to come to market featuring technologies licensed by TAP from Specialized Health Products International (SHPI).
Needlestick injury is a cause of occupational injury among healthcare workers in the United States. The Occupational Safety and Health Administration (OSHA) estimates that between 600,000 and 800,000 needlestick and similar injuries occur on the job each year. Approximately 5.6 million workers in the healthcare industry and related occupations are at risk of transmission of more than twenty different bloodborne pathogens, including HIV, hepatitis B virus and hepatitis C virus. Studies show that nurses sustain the majority of these injuries. In addition, overall incidence may be under-reported.
Although it is not possible to completely eliminate the risk of needlestick injury for healthcare professionals, research estimates between 62-88 percent of sharps injuries could be reduced through the use of devices and procedures designed to protect healthcare workers from exposed needles.
With the FDA approval of LuproLoc, Lupron Depot has become the first drug in its class to offer a safety device already attached to a pre-filled syringe, which is designed to enhance safety for healthcare professionals who administer Lupron Depot to patients. LuproLoc's design assists healthcare professionals in complying with the FDA's recommendations for safer needle devices, including the recommendation that a device provide a barrier between the hands and the needle after use.
SHPI's proprietary safety needle technology is adaptable to a wide variety of prefillable syringes. The technology provides unique, one-handed activation, and is designed for easy integration into pharmaceutical manufacturing.
SHPI designs, develops, manufactures, and licenses cost-effective, innovative safety healthcare products that minimize the risk of accidental needlesticks, which are a leading cause of the spread of bloodborne diseases such as HIV/AIDS and hepatitis B and C. SHPI has twenty highly differentiated, patented safety needle technologies. These technologies apply to almost all medical needles used today, including: syringe, prefilled syringes, IV catheter, Seldinger, PICC introducer needles, winged needle sets, blood collection, epidural, spinal, plasma apheresis sets, dialysis sets, Huber, biopsy and other specialty needles.
TAP Pharmaceutical Products Inc., located in Lake Forest, Ill., is a joint venture between Abbott Laboratories and Takeda Chemical Industries, Ltd.
Source: Abbott Laboratories