PHARMACY

FDA grants final approval for Caraco’s generic Metaglip

BY Drew Buono

DETROIT The Food and Drug Administration has granted final approval to Caraco Pharmaceutical Laboratories application for glipizide/metformin hydrochloride tablets 2.5/250 mg, 2.5/500 mg and 5/500 mg.

The drugs are a generic version of Bristol-Myers Squibb’s drug Metaglip. It is indicated as initial therapy, as an adjunct to diet and exercise, to improve glycemic control in patients with Type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone. It is also indicated as second-line therapy when diet, exercise, and initial treatment with a sulfonylurea or metformin do not result in adequate glycemic control in patients with Type 2 diabetes

According to IMS data, for the 12 months that ended September 2007, the generic and brand products of the drug had combined annual sales of about $25 million.

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FDA to open office in India

BY Drew Buono

KOCHI The Food and Drug Administration is planning on opening an office of its agency in India, in an effort to ensure the quality of the food and drugs being imported by the U.S., according to published reports.

Health and Human Service secretary Michael Leavitt and FDA commissioner Andrew von Eschenbach are in the country presently assessing the manufacturing practices existing at drug and food processing units.

According to Leavitt, he set up the mission because, “there was a serious apprehension among the consumers in this country on the quality of food and drugs being imported.” “We are trying to ensure the quality in the entire system of supply chain, right from the seed to the last outlet from where people buy the goods,” he said.

The U.S. imports about $56 million worth of food and drug products from India.

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BioDelivery works on risk management plan for dissolving fentanyl patch

BY Drew Buono

RALEIGH, N.C. BioDelivery Services International is planning on developing a safety plan for its new BEMA fentanyl patch, which the Food and Drug Administration accepted for review last week, according to published reports.

In December, a public health advisory from the FDA was released following reports of life-threatening side effects and even death associated with inappropriate prescriptions or use of the patches. So, to be safe, BioDelivery has developed a Risk Minimization Action Plan, or RiskMap, for its patch, which dissolves in the mouth and is placed on the walls of the cheek, unlike other fentanyl patches, which are placed on the skin and have to be disposed of.

Fentanyl is a narcotic pain medication more powerful than morphine. It has been in use for years. The FDA first issued a public health advisory for fentanyl skin patches in July 2005 following reports of the deaths of some patients.

BioDelivery’s vice president of marketing stated that the company is more confident as to the differences between its patch and other fentanyl patches, and believes the confidence is extended to how the drug is meant to be used and how the drug is delivered in the body.

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