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FDA approves generic Aricept for dementia

The US FDA has approved a generic version of Eisai's Aricept for the treatment of dementia related to Alzheimer's disease

The US Food and Drug Administration (FDA) has approved a generic version of Eisai's Aricept (donepezil hydrochloride) for the treatment of dementia related to Alzheimer's disease.

The generic orally disintegrating donepezil hydrochloride tablets that have been approved are manufactured by Philadelphia-based Mutual Pharmaceutical and are available in 5mg and 10mg strengths.

The therapy is administered as a tablet that dissolves on the tongue, making it easier for the elderly and those with trouble swallowing, to receive the medication.

"Generics offer greater access to health care for all Americans," said Gary Buehler, director of the FDA's Office of Generic Drugs. "Health care professionals and consumers can be assured that FDA-approved generic drugs have met the same rigorous standards as the brand-name drug and are the same as the branded in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use."  


Elan stops Alzheimer's drug trial after deaths
Dublin-based Elan, and its partner Transition Therapeutics, have removed two high doses of their experimental orally-administered Alzheimer's therapy from a phase II trial following the deaths of nine patients.

No direct relationships between the deaths of the patients and the experimental ELND005 compound have been made. However, all nine patients who died were receiving either 1000mg or 2000mg of the drug. Trials of a lower 250mg dose will continue. All three volumes of the drug were administered twice daily. 

"Today's decision speaks to our strong commitment to patient safety while allowing for the continued evaluation of ELND005 at the 250mg dose, twice daily," said Dr Menghis Bairu, EVP, chief medical officer and head of global development at Elan. "We continue to expect the ongoing study to provide important data to guide the next steps in the development of ELND005 for the potential treatment Alzheimer's disease."

ELND005 has received fast track designation from the US FDA for treatment of mild to moderate Alzheimer's disease.

Fast track designation can facilitate development and may expedite regulatory review of drugs that the FDA recognises as potentially addressing an unmet medical need for serious or life-threatening conditions.

16th December 2009


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