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Orexo's Zubsolv receives FDA nod
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.
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FDA gives tentative approval to Mylan's generic Crestor
SILVER SPRING, Md. — Mylan has received tentative approval for a generic version of a cholesterol drug made by AstraZeneca, according to Food and Drug Administration records.
The FDA gave the tentative approval to Mylan's rosuvastatin calcium tablets in the 5 mg, 10 mg, 20 mg and 40 mg strengths. The drug is a generic version of AstraZeneca's Crestor, which had sales of $5.1 billion in 2012, according to IMS Health.
