PharmiWeb.com - Global Pharma News & Resources
13-Dec-2018

Virtus Announces FDA Approval of its AB Rated Generic Levorphanol Tartrate 2mg Tablets CII

Virtus Pharmaceuticals, LLC, a specialty pharmaceutical company, today announced it has received an AB therapeutic equivalent rating and final U.S. Food and Drug Administration ("FDA") approval on its Abbreviated New Drug Application ("ANDA") for a generic version of Levorphanol Tartrate 2 mg immediate release tablets. The application received a Competitive Generic Therapy (“CGT”) designation from the FDA and upon the commencement of commercial marketing is deemed eligible for a 180-day period of marketing exclusivity. The product is being launched with an approved Risk Evaluation and Mitigation Strategy (REMS) Program.

The company is preparing for launch to the market immediately and further working to obtain Drug Enforcement Administration (“DEA”) API quota to secure sufficient supply to meet anticipated market demand. Until such time Virtus expects, product supplies to be limited.

Levorphanol Tartrate 2 mg immediate release tablets had U.S sales of approximately $94 million, according to IQVIA for the 12 months ending October 2018.

Important Safety Information

WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Addiction, Abuse, and Misuse

Levorphanol Tartrate Tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing Levorphanol Tartrate Tablets, and monitor all patients regularly for the development of these behaviors and conditions [see WARNINGS].

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) :

To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products [see Warnings]. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to

  • complete a REMS-compliant education program,
  • counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,
  • emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and
  • consider other tools to improve patient, household, and community safety.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of Levorphanol Tartrate Tablets. Monitor for respiratory depression, especially during initiation of Levorphanol Tartrate Tablets or following a dose increase [see WARNINGS].

Accidental Ingestion

Accidental ingestion of Levorphanol Tartrate Tablets, especially by children, can result in a fatal overdose of Levorphanol Tartrate Tablets [see WARNINGS].

Neonatal Opioid Withdrawal Syndrome

Prolonged use of Levorphanol Tartrate Tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see WARNINGS].

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see WARNINGS].

  • Reserve concomitant prescribing of Levorphanol Tartrate Tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
  • Limit dosages and durations to the minimum required.
  • Follow patients for signs and symptoms of respiratory depression and sedation.

MEDICATION GUIDE
Levorphanol Tartrate
(lee vor’ fa nol tar’ trate)
Tablets CII

Levorphanol Tartrate Tablets are:

  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain, severe enough to require an opioid pain medicine when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
  • An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Important information about Levorphanol Tartrate Tablets:

  • Get emergency help right away if you take too much Levorphanol Tartrate Tablets (overdose). When you first start taking Levorphanol Tartrate Tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
  • Taking Levorphanol Tartrate Tablets with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma and death. Never give anyone else your Levorphanol Tartrate Tablets. They could die from taking it. Store Levorphanol Tartrate Tablets away from children and in a safe place to prevent stealing or abuse. Selling or giving away Levorphanol Tartrate Tablets is against the law.

Do not take Levorphanol Tartrate Tablets if you have:
severe asthma trouble breathing, or other lung problems
a bowel blockage or have narrowing of the stomach or intestines.
previously had an allergic reaction to levorphanol

Before taking Levorphanol Tartrate Tablets, tell your healthcare provider if you have a history of:

  • head injury, seizures
  • liver, kidney, thyroid problems
  • problems urinating
  • pancreas or gallbladder problems
  • abuse of street or prescription drugs, alcohol addiction, or mental health problems.

Tell your healthcare provider if you are:

  • pregnant or planning to become pregnant. Prolonged use of Levorphanol Tartrate Tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • breastfeeding. Levorphanol Tartrate Tablets passes into breast milk and may harm your baby.
  • taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Levorphanol Tartrate Tablets with certain other medicines can cause serious side effects that could lead to death.

When taking Levorphanol Tartrate Tablets:

  • Do not change your dose. Take Levorphanol Tartrate Tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
  • Take your prescribed dose every 6 to 8 hours as needed for pain. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
  • Call your healthcare provider if the dose you are taking does not control your pain.
  • If you have been taking Levorphanol Tartrate Tablets regularly, do not stop taking without talking to your healthcare provider.
  • After you stop taking Levorphanol Tartrate Tablets, flush all unused tablets down the toilet.

While taking Levorphanol Tartrate Tablets DO NOT:

  • Drive or operate heavy machinery, until you know how Levorphanol Tartrate Tablets affects you. Levorphanol Tartrate Tablets can make you sleepy, dizzy, or lightheaded.
  • Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with Levorphanol Tartrate Tablets may cause you to overdose and die. The possible side effects of Levorphanol Tartrate Tablets:
  • constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help if you have:

  • trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

These are not all the possible side effects of Levorphanol Tartrate Tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.

For more information you can call 1-888-848-3593.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distributed by:
Virtus Pharmaceuticals, LLC
Langhorne, PA 19047

Rev. 10/2018
OS412V-01-1-01

View source version on businesswire.com: https://www.businesswire.com/news/home/20181213005817/en/

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Last Updated: 13-Dec-2018