FDA解决大动物大容量静脉注射液的缺口问题

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FDA Addressing the Shortage of Large Volume Intravenous Solutions

April 13, 2015

The U.S. Food and Drug Administration’s Center for Veterinary Medicine is coordinating with drug companies to increase the availability of three- to five-liter （3-5L)intravenous (IV) fluids intended to provide large animals with IV fluid replacement therapy.

The current shortage has been triggered by several factors, including increased demand combined with reduced manufacturing of the sizes most suitable for use in large animals. Because of a shortage of IV fluids for use in both human and veterinary medicine, some manufacturers have focused on manufacturing the smaller sizes for humans and small animals, which has contributed to a decrease in the availability of the three-liter and five-liter sizes that are used in large animals.

The FDA is working with drug companies to address the current shortage and meet the long-term demand for IV fluids. To address the immediate need, the FDA will temporarily exercise enforcement discretion over the importation of large volume IV solutions that are currently marketed in foreign countries and carry labeling appropriate for those countries. Several companies are currently preparing to import five-liter fluids into the U.S. As products become available, we will update ourdrug shortages - IV Fluids page with additional information.

The FDA is working to ensure continued, long-term availability of these products, as well as ensuring that the products are produced and marketed in a manner that is consistent with Compliance Policy Guide, CPG Sec. 635.100 Large Volume Parenterals (LVP's) for Animal Use.

For manufacturing and availability updates on IV fluids (≤1L) for use in people, please see:http://www.fda.gov/Drugs/DrugSafety/ucm382255.htm.

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Current Drug Shortages

This page contains up-to-date information on current shortages of medically necessary veterinary products.

When drug shortages involve medically necessary veterinary products, it is FDA’s policy to help prevent or alleviate them. FDA works with drug manufacturers in the U.S. and, when necessary, other countries, to find ways to resolve these shortages. FDA does not have the authority to require a company to make any product, even if it is medically necessary.

Date

Product

Company Information

Reason

4/13/2015IV Fluids for Animal Use, 3L & 5L volume size
动物用3-5L静脉注射液Various companiesDemand Increase, Reduction in the manufacturing of 3L & 5L volume size
(updated)
8/1/2013Adequan I.A.; Adequan I.M.; Adequan Canine
动脉、肌内牛血代血浆，？？？Luitpold Pharmaceuticals Inc.

http://www.adequan.com/index.aspx

Manufacture delay
11/28/2011Atropine Sulfate
硫酸阿托品Sparhawk Laboratories, Inc.
http://www.sparhawklabs.com
Customer Service – 800-255-6368Limited supply has been made available for distribution.
Manufacture delay
11/10/2010Epinephrine
肾上腺素RVX distributed by Teva
http://www.tevapharm.comDiscontinued distribution
3/14/2010Immiticide (melarsomine dihydrochloride)
美拉索明盐酸盐Merial Limited
http://us.merial.com/
678-638-3000Manufacturer site delay

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