Spectra Medical Devices - Huons Co., Ltd. are proud to announce the FDA approval of their Abbreviated New Drug Application (ANDA) for Bupivacaine HCl with Dextrose USP, 0.75% / 8.25% in 2 mL ampules.
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WILMINGTON, Massachusetts, Jan. 13, 2020 /PRNewswire/ -- Spectra Medical Devices - Huons Co., Ltd. are proud to announce the FDA approval of their Abbreviated New Drug Application (ANDA) for Bupivacaine HCl with Dextrose USP, 0.75% / 8.25% in 2 mL ampules. The product is now available along with previously approved ANDA's for Lidocaine HCl Injection, USP, 5mL ampules and Sodium Chloride Injection USP, 0.9% in 5ml and 10ml ampules. "With this FDA approval, we are now able to meet the United States demand for Bupivacaine, which currently is in limited supply nationally. Supplying Bupivacaine with Dextrose in ampules to health care providers, a product which has not been readily available, along with the largest range of custom procedural needles, is significant news for physicians and Spectra," noted Tony Arrigo, President & CEO of Spectra Medical Devices.
Spectra Medical Devices is one of the largest procedural needle manufacturers in the world, with substantial market share in over 20 countries. Spectra utilizes the latest state-of-the-art manufacturing and inspection systems, along with over 225 years of experience in manufacturing needles. Spectra operates 5 manufacturing plants worldwide with 300 employees. Corporate headquarters are located in Wilmington, Massachusetts. Spectra Medical Devices, Inc. was founded in 1995 by Tony Arrigo and is celebrating its 25th Anniversary. Mr. Arrigo was previously President & CEO and owner of American Medical Instruments, Inc. in Massachusetts which is now the needle division of Tegra Medical. Spectra has been granted several US patents for specialized needle processing and products. Spectra Medical's primary focus is on patient safety, achieving substantial growth through quality and innovation. To order Bupivacaine 0.75% in Dextrose in 2 mL ampules, contact Anthony Arrigo, Director, Global Sales & Marketing at sales@spectramedical.com (978) 657-0889 ext. 5231. Contact:
SOURCE Spectra Medical Devices, Inc. |
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