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Orexo’s Zubsolv receives FDA nod

BY Alaric DeArment

NEW YORK — The Food and Drug Administration has approved a new drug for treating opioid dependence.

Orexo U.S. announced the approval of Zubsolv (buprenorphine; naloxone) sublingual tablets. The drug, Schedule III controlled substance, is approved for use once per day in the maintenance treatment of opioid dependence. Opioid dependence affects nearly 5 million people in the United States, according to the Substance Abuse and Mental Health Services Administration, but about 60% of those affected don’t receive treatment.

"Orexo is committed to helping patients suffering from opioid dependence effectively manage their condition," Orexo president Robert DeLuca said. "The advanced formulation of Zubsolv was developed using our proprietary technology to meet the needs of patients not satisfied with previously approved buprenorphine-naloxone formulations."


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Amgen, Servier enter $50 million heart drug development deal

BY Alaric DeArment

THOUSAND OAKS, Calif. — Amgen will get rights to a drug for cardiovascular disease approved in the European Union under a new deal with French drug maker Servier, the two companies said Tuesday.

The drug, Procoralan (ivabradine) is used to threat chronic heart failure and stable angina in patients with elevated heart rates, and Amgen will also have an exclusive option to develop and commercialize an experimental Servier drug, S38844, for cardiovascular disease in the United States. That drug is currently in mid-stage clinical trials. The deal includes a $50 million upfront payment from Amgen plus future milestone and royalty payments.

"A critical unmet medical need remains for patients who don’t respond adequately to current available therapies for heart failure and angina," Amgen EVP research and development Sean Harper said.


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FDA marks GDUFA milestones

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration has made a significant dent in its large backlog of generic drug applications thanks to amendments to last year’s reauthorization of the Prescription Drug User Fee Act, the agency said Tuesday.

The FDA’s Center for Drug Evaluation and Research said its Office of Generic Drugs had finished reviewing more than 30% of backlog applications since the passage of the Generic Drug User Fee Amendments while streamlining the process of hiring new scientific reviewers, project managers, investigators and support staff. The FDA plans to bring on board at least 25% of GDUFA program hires by the beginning of October.

In addition, the agency has put in place other improvements designed to ease communication between it and drug companies during the review process, including more detailed complete-response letters, letters the FDA sends to companies when it has completed reviewing a drug-approval application, but issues remain that preclude final approval.

The amendments were part of an effort to improve the generic drug review system at the FDA, which had long struggled with a backlog of more than 2,000 generic drug applications due to insufficient staffing and funding.


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