5 drugs awaiting FDA review in October

The Food and Drug Administration has approved 17 new drugs in 2016, with several regulatory decisions set to be made in October, according to Zacks Investment Research.

Here are five drugs the FDA will approve or deny this month.

  1. Tecentriq, developed by Basel, Switzerland-based Roche, is an immunotherapy drug under FDA review to treat patients with non-small cell lung cancer. Roche, which earned priority review status for the drug, expects a decision Oct. 19.

  2. Paris-based Sanofi and Tarrytown, N.Y.-based Regeneron Pharmaceuticalsdeveloped Sarilumab for patients with moderate to severe rheumatoid arthritis. The companies expect a response from the FDA Oct. 30.

  3. Kenilworth, N.J.-based Merck will learn if its drug Zinplava has been approved to prevent a recurrence of C. difficile infection in adult patients Oct. 23.

  4. Xtandi, which New York City-based Pfizer recently acquired from San Francisco-based Medivation, is a prostate cancer drug. On Oct, 22, the FDA will decide whether to approve a label change on the drug that would boost sales for Pfizer.

  5. Egalet, a specialty pharma company in Wayne, Pa,. developed Arymo ER to treat pain severe enough to require daily, long-term opioid treatment when alternative medications do not work. The FDA is expected to make a decision on the drug's status on Oct. 14.

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