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FDA issues new guidelines for budeprion XL in the 300-mg strength

BY Allison Cerra

WASHINGTON — The Food and Drug Administration has reviewed new data that indicated that budeprion XL (bupropion hydrochloride extended-release tablets) in the 300-mg strength, manufactured by Impax Labs and Teva Pharmaceuticals USA, is not therapeutically equivalent to Wellbutrin XL in the 300-mg strength.

The agency said that when it approved five generic versions of the antidepressant in the 300-mg strength, each of these generics was approved based on bioequivalence studies comparing the 150-mg strength of the products with Wellbutrin XL in the 150-mg strength. Studies, however, were not performed directly on the 300-mg strength of the products, but rather, bioequivalence studies were performed using the 150-mg strength and the results were extrapolated to establish bioequivalence of the 300-mg product, the agency said.

"[The] FDA has determined that this approach is no longer appropriate to establish bioequivalence of 300-mg bupropion hydrochloride extended-release tablets to Wellbutrin XL 300 mg, and the agency is revising its guidance to industry for how to conduct premarket bioequivalence studies in generic bupropion products," the FDA said in a statement, adding that it has changed the therapeutic equivalence rating for this product in the agency’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) to reflect this conclusion.

The move has drawn praise from the industry, particularly, the Generic Pharmaceutical Association.

"We commend the FDA for its ongoing commitment to ensuring the safety and efficacy of generic medicines," GPhA president and CEO Ralph Neas said. "Our manufacturers are dedicated to complying with FDA guidelines and providing high quality and affordable medicines to consumers and will continue their work with the agency to fulfill our joint commitment to patients. Assuring the safety and efficacy of the prescription drugs we supply is priority one. The fact that the FDA can rely on its scientific expertise to make critical decisions regarding the safety and effectiveness of pharmaceuticals &dmash; whether brand name or generic — is the surest evidence that our rigorous regulatory controls are working."


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FDA, Interpol collaborate on crackdown of illegal Web pharmacies

BY Michael Johnsen

SILVER SPRING, Md. — In partnership with international regulatory and law enforcement agencies, the Food and Drug Administration on Thursday announced it had taken action against more than 4,100 Internet pharmacies that illegally sell unapproved drugs to consumers. Actions taken include civil and criminal charges, seizure of illegal products and removal of offending websites.

“Consumers in the United States and around the world face a real threat from Internet pharmacies that illegally sell potentially substandard, counterfeit, adulterated or otherwise unsafe medicines,” stated FDA Commissioner Margaret Hamburg. “This week’s efforts show that strong international enforcement efforts are required to combat this global public health problem. The FDA is committed to joining forces to protect consumers from the risks these websites present.”

Last week, the FDA reinforced its online efforts with the launch of a national campaign to educate Americans about the risks of buying prescription medications over the Internet. BeSafeRx – Know Your Online Pharmacy seeks to raise public awareness about the health risks of using fraudulent Internet pharmacies and what consumers can do to protect themselves.

The announcement takes place during the fifth annual International Internet Week of Action, a global cooperative effort to combat the online sale and distribution of potentially counterfeit and illegal medical products. This year’s effort, Operation Pangea V, operated between Sept. 25 and Oct. 2 and resulted in the shutdown of more than 18,000 illegal pharmacy websites and the seizure of about $10.5 million worth of pharmaceuticals worldwide.

The goal of this annual effort — which involved law enforcement, customs and regulatory authorities from 100 countries — is to identify producers and distributors of illegal pharmaceutical products and medical devices and remove these products from the supply chain.

During Operation Pangea V, the FDA targeted websites selling unapproved and potentially dangerous medicines. In many cases, the medicines can be detrimental to public health because they contain active ingredients that are approved by FDA for use only under the supervision of a licensed healthcare practitioner or active ingredients that were previously withdrawn from U.S. market due to safety issues.

Among the illegal medicines identified through the operation were:

  • Domperidone: This medicine was removed from the United States market in 1998 because it may cause serious adverse effects, including irregular heartbeat, stopping of the heart or sudden death. These dangers could convey to the nursing baby of breast-feeding women, who may be using domperidone to try increase milk production, which is not an approved use;

  • Isotretinoin (previously marketed as Accutane in the United States): This medicine is used to treat severe nodular acne and carries significant potential risks, including severe birth defects if pregnancy occurs while using this medicine. To minimize potential risks to consumers, FDA-approved isotretinoin capsules are only available through restricted distribution in the United States;

  • Tamiflu (oseltamivir phosphate): This medicine, which is used to treat the flu, is often sold online as “generic Tamiflu.” However, there is no FDA-approved generic version of Tamiflu. Previous FDA tests found that fraudulent versions of “generic Tamiflu” contained the wrong active ingredient, which would not be effective in treating flu. In these cases, the wrong active ingredient was similar to penicillin and may cause a severe allergic reaction, including a sudden, potentially life-threatening reaction called anaphylaxis, in consumers allergic to penicillin products; and

  • Viagra (sildenafil citrate): This medicine is used to treat erectile dysfunction. Due to its vasodilation effects, sildenafil citrate should not be used by consumers with certain heart conditions. Consumers taking this medicine without the supervision of a healthcare professional may not learn about potential drug interactions, such as increased blood pressure-lowering effects of organic nitrates when taken with sildenafil citrate. Many Web entities illegally market these products as dietary supplements. 

The FDA sent warning letters to the operators of more than 4,100 identified websites. As a follow-up, the agency sent notices to registries, Internet service providers and domain name registrars informing them that these websites were selling products in violation of U.S. law. The FDA is working with its foreign counterparts to address the remaining websites that continue to offer unapproved or misbranded prescription medicines to U.S. consumers.

“Internet pharmacies that illegally sell unapproved, counterfeit or potentially adulterated or substandard drugs are an inherently international crime problem,” stated John Roth, director of the FDA’s Office of Criminal Investigation. “The FDA is pleased to work with Interpol, the international police agency, to fight this problem. Because these criminals do not respect international borders, the international coordinated law enforcement response represented by Operation Pangea demonstrates that international cooperation is the best way to protect the American public from the risk of unsafe drugs.”


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o.munoz says:
Jun-19-2013 11:18 pm

Finally an article that is not the same thing we hear over and over again. I appreciate your thought and insight into this subject matter. thanks for sharing this with us. http://binare-optionen-wir-wissen-wie-man-geld-verdient.blogg.asia/

K.KUMAR says:
Nov-08-2012 05:11 am

They need to take quick action against illegal sale of drugs and banned on such pharmacies and have punish with double fine charge. http://www.promos10.com

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Kroger becomes part of USHCC Million Dollar Club

BY Allison Cerra

CINCINNATI — Kroger has become a member of the U.S. Hispanic Chamber of Commerce Million Dollar Club. The USHCC Million Dollar Club recognizes corporations that are leaders in supplier diversity and integrating Hispanic business enterprises into their strategic sourcing and procurement process. Corporations qualify by spending between $25 million to more than $500 million with Hispanic suppliers in the previous year.

This is Kroger’s third consecutive year of qualifying for membership.

"Kroger is honored to be selected for membership in the Million Dollar Club," Kroger’s chief diversity officer Reuben Shaffer said. "Our partnerships with diverse suppliers help us meet our customers’ needs and create employment opportunities in the local communities we serve."

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