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Buprenorphine

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Buprenorphine Notices

Notice of Inspection of Controlled Premises
A Notice of Inspection of Controlled Premises (Form DEA-82) must be signed prior to a DATA 2000 inspection. It includes a statement of physicians' rights as well as an authorization to inspect the controlled premises. Use this link to go to a copy of a blank notice form.
Generic Subutex Approved
October 8, 2009—Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Buprenorphine HCl Sublingual Tablets, 2mg and 8mg, by the U.S. Food and Drug Administration. The product is available in bottles of 30 for immediate shipment to wholesalers and pharmacies nationwide. Roxane Laboratories' Buprenorphine HCl Sublingual Tablets are AB rated to Subutex® (buprenorphine HCl) tablets. Annual sales of Subutex® are approximately $67.7 million.

Full prescribing information for Buprenorphine HCl Sublingual Tablets is available on the Roxane Laboratories website at www.Roxane.com or upon request by calling Roxane Laboratories Technical Product Information at 1.800.962.8364.
SAMHSA Issues Nationwide Public Health Alert Concerning Life Threatening Risk Posed by Cocaine Laced with Veterinary Anti-Parasite Drug
September 18, 2009—SAMHSA is alerting medical professionals, substance abuse treatment centers, and other public health authorities about the risk that substantial levels of cocaine may be adulterated with levamisole—a veterinary anti-parasitic drug. As of this date, there have been approximately 20 confirmed or probable cases of agranulocytosis (a serious, sometimes fatal blood disorder), including two deaths, associated with cocaine adulterated with levamisole. The number of reported cases is expected to increase as information about cocaine adulterated with levamisole is disseminated. Use this link to go to the letter.
SAMHSA and DEA Issue Letter on Prescribing Suboxone/Subutex in Opioid Treatment Programs
April 27, 2009—This letter sets forth the current Federal regulations regarding a physician's authority, while employed by an Opioid Treatment Program (OTP) certified by SAMHSA and registered with the Drug Enforcement Administration (DEA) as a Narcotic Treatment Program (NTP) (hereinafter OTP), to prescribe, write orders for, or dispense Suboxone® or Subutex® to patients for addiction/dependence treatment under the provisions of the Drug Addiction Treatment Act of 2000 (DATA 2000). Use this link to go to the letter.

 


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