PHARMACY

Sandoz gets green light for two generic Alzheimer’s disease drugs

BY Alaric DeArment

PRINCETON, N.J. — Sandoz has launched generic versions of treatments for Alzheimer’s disease, the generic pharmaceuticals division of Swiss drug maker Novartis said Wednesday.

Sandoz announced the launch of donepezil hydrochloride film-coated tablets and donepezil hydrochloride orally disintegrating tablets, which are generic versions of Eisai and Pfizer’s Aricept and Aricept ODT, respectively.

Donepezil hydrochloride film-coated and orally disintegrating tablets had sales of $2.3 billion in the 12-month period ended in March, according to IMS Health.

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‘Physicians’ Desk Reference’ publisher looks to share wealth of information with consumers

BY Alaric DeArment

MONTVALE, N.J. — Unless they’re doctors themselves, patients typically don’t have the expertise of someone who went to medical school. But the company that publishes the reference book doctors look to for information about prescription drugs is helping to share some of the knowledge.

PDR Network, publisher of the “Physicians’ Desk Reference,” announced Wednesday the launch of the PDR Consumer Book imprint and its first title, the “PDR Consumer Guide to Prescription Drugs,” a reference that provides information about prescription drugs in a way that’s easier for consumers to read and understand.

“We are very excited to launch this new imprint and new title for those consumers who take an active interest in all aspects of their health,” PDR Network SVP Andrew Gelman said. “This guide allows consumers to better understand the medications they are taking, empowering them to partner with their physicians to optimize their well-being.”

The book, which includes a forward by Preventive Medicine Research Institute president and New York Times best-selling author Dean Ornish, will be available in bookstores, through online retailers and PDR’s consumer drug information portal, PDRhealth.com.

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XTL granted orphan drug designation for multiple myeloma treatment

BY Alaric DeArment

HERZLIYA, Israel — The Food and Drug Administration has given orphan drug designation to an investigational treatment for multiple myeloma, a blood cell cancer, that soon will enter mid-stage development.

XTL announced that the FDA had granted the designation to its recombinant human erythropoietin, or rHuEPO drug, for which the company soon will start phase-2 clinical trials.

The FDA gives orphan drug designation to treatments for diseases that affect fewer than 200,000 people in the United States per year.

While an orphan drug still must undergo the agency’s standard regulatory approval procedures, the designation entitles it to extended market exclusivity periods, tax credits for research and development expenses and exemptions from payment of commissions to the FDA.

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