Business & Finance
FDA Advisory Committees Approve Teva's Vantrela ER Extended-Release Tablets CII
8 June 2016 - - The Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the US Food and Drug Administration voted 14 to 3 to recommend approval of  Israeli generic medicines producer Teva Pharmaceutical Industries Ltd.'s (NYSE: TEVA) (TASE: TEVA) Vantrela ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate, the company said.

Vantrela ER is an extended-release formulation of hydrocodone bitartrate with Teva's proprietary abuse deterrence technology.

Based on the committees' votes, Teva anticipates, if approved, the label for Vantrela ER will describe the product's abuse-deterrent properties that are expected to reduce, but not totally prevent, abuse of the drug when the tablets are manipulated.

The FDA is not bound by the recommendations of its advisory committees, but will consider their guidance during the review of the New Drug Application for Vantrela ER.

Adverse events reported in five % or more of hydrocodone-treated patients during either the titration or double-blind treatment periods included: nausea, constipation, vomiting, headache, somnolence, itching and dizziness.

Headquartered in Israel, Teva is the world's largest generic medicines producer, leveraging its portfolio of more than 1,000 molecules to produce a range of generic products in nearly every therapeutic area.

The company's net revenues in 2015 amounted to USD 19.7bn.
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