Elite Pharmaceuticals Inc (ELTP)

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Teva Receives FDA Approval for VANTRELATM ER (Hydrocodone Bitartrate) Extended-Release Tablets [CII] Formulated with Proprietary Abuse Deterrence Technology
BUSINESS WIRE 8:00 AM ET 1/18/2017
Symbol Last Price Change
TEVA 33.75 0 (0%)
QUOTES AS OF 04:00:21 PM ET 01/17/2017
VANTRELA ER label describes the product’s abuse-deterrent properties against abuse in the three most
common routes—oral, intranasal and intravenous

JERUSALEM--(BUSINESS WIRE)-- Teva Pharmaceutical Industries Ltd.(TEVA) today announced the U.S. Food and Drug Administration (FDA) approved VANTRELATM ER (hydrocodone bitartrate) extended-release tablets [CII] formulated with Teva’s proprietary abuse deterrence technology. VANTRELA ER is indicated 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 product’s approval is supported by a clinical program that evaluated the safety and efficacy of VANTRELA ER, as well as its abuse potential in laboratory-based in vitro manipulation and extraction studies, pharmacokinetic studies, and clinical abuse potential (CAP) studies.

“Teva understands the risk of prescription drug abuse is a challenge healthcare professionals face when treating millions of Americans affected by chronic pain,” said Rob Koremans, MD, President and CEO of Global Specialty Medicines at Teva. “Abuse-deterrent treatments provide options for prescribers that may help deter or mitigate abuse while still preserving access to pain medications for the patients that need them most.”

The VANTRELA ER prescribing information (PI) describes the product’s abuse-deterrent properties that are expected to reduce, but not totally prevent, oral, intranasal and intravenous abuse of the drug when the tablets are manipulated. As an opioid, VANTRELA ER is associated with serious risks and the PI contains a Boxed Warning that includes addiction, abuse, and misuse, which can lead to overdose and death, as well as serious, life-threatening, or fatal respiratory depression. Additional boxed warnings and other important safety information can be found below and in the prescribing information.

Michael Hayden, MD, PhD, President of Global R&D and Chief Scientific Officer at Teva said, “While no technology can completely eliminate abuse, Teva’s proprietary abuse deterrence technology is an important step forward. We are committed to furthering responsible pain management.”

Adverse reactions in ≥2% of patients in placebo-controlled trials include nausea, constipation, headache, somnolence, vomiting, dizziness, pruritus, fatigue, dry mouth, diarrhea, insomnia, and anxiety.

ABOUT VANTRELA ER

VANTRELA™ ER (hydrocodone bitartrate) extended-release tablets [CII] is an opioid agonist indicated 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.

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Look for TEVA to soon submit ANDA ER Oxycontin and challenge Purdue. Teva and others collectively won the Federal Court approval against Purdue in Feb 2016.

http://www.reuters.com/article/us-oxycontin-ruling-idUSKCN0VA3GC

IMO also $ELTP with their ANDA Oxycontin and other Pharmas will all issue their Oxycontin ANDAs in 2017 and collectively challenge Purdue should Purdue try to sue again on its frivolous Oxycontin Patent Extension claims.