Lineage Therapeutics Markets Authorized Generic Epinephrine Auto-Injector

HORSHAM, Pa., June 14, 2013 /PRNewswire/ -- Lineage Therapeutics Inc. has announced the US launch of its generic epinephrine injection, USP auto-injector, the authorized generic of Adrenaclick® by Amedra Pharmaceuticals LLC, for the emergency treatment of life-threatening allergic reactions in people who are at risk for or have a history of anaphylaxis. The product is available as a two-pack carton in both 0.15 mg and 0.30 mg strengths.

Lineage’s epinephrine auto-injector is the only generically priced epinephrine auto-injector currently available. This authorized generic epinephrine injection, USP auto-injector, is being reintroduced to the market as it was previously marketed under prior ownership.

According to Dr. F. Estelle R. Simons, Professor, Department of Pediatrics & Child Health at the University of Manitoba, “There is a long-standing need for an inexpensive epinephrine auto-injector.”

Epinephrine Auto-Injectors, 0.15 mg and 0.30 mg, had U.S. sales of approximately $758 million for the 12 months ending April 30, 2013, according to IMS Health.

For additional information about epinephrine, USP auto-injector including full prescribing information, please visit the website at: www.epinephrineautoinject.com.

About Anaphylaxis

Anaphylaxis is a potentially life-threatening allergic reaction that is rapid in onset and may cause severe swelling, breathing problems, loss of blood pressure, and death. Allergic reactions can be caused by stinging and biting insects (bugs), allergy injections, food, medicines, exercise, or unknown causes. Symptoms may include closing of the breathing airways, wheezing, sneezing, hoarseness, hives, itching, swelling, skin redness, fast heartbeat, weak pulse, feeling very anxious, confusion, and stomach pain. Epinephrine is the medicine of choice for someone experiencing an anaphylactic reaction. Prompt recognition of the signs and symptoms of anaphylaxis is crucial.

Important Safety Information

• Make sure to tell your doctor about all your medical conditions and allergies, but especially if you:
  • have heart disease or high blood pressure
  • have diabetes
  • have thyroid conditions
  • have asthma
  • have depression or other mental disease
  • have Parkinson’s disease
  • are pregnant
  • are allergic to any of the ingredients in epinephrine auto-injector
• Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Some medicines may cause serious side effects if taken while you use epinephrine auto-injector. Some medicines may affect how epinephrine auto-injector works, or epinephrine auto-injector may affect how your other medicines work.
• Avoid injecting epinephrine auto-injector into your buttock or any other part of your body, other than the middle of the outer side of your thigh (upper leg). Avoid injecting epinephrine auto-injector into a vein.
• Too much epinephrine (epinephrine auto-injector) can cause dangerously high blood pressure, stroke, or death. If you take certain medicines, you may develop serious life-threatening side effects from the epinephrine in epinephrine auto-injector. Be sure to tell your doctor about all the medicines you take, especially medicines for asthma.
• Patients with certain medical conditions, or who take certain medicines, may get more side effects from epinephrine auto-injector, or the side effects may last longer. This includes patients who take certain types of medicines for asthma, allergies, depression, hyperthyroidism, high blood pressure, and heart disease. Patients with heart disease may feel chest pain (angina). Patients with mental disease or Parkinson’s disease may have worsening symptoms of their illness. Epinephrine auto-injector (epinephrine) can cause the following reactions. Some reactions can be serious. They usually go away with rest.
  • faster, irregular (wrong) or “pounding” heartbeat
  • throbbing headache
  • paleness
  • feelings of over excitement, anxiety, or fear
  • weakness or shakiness
  • dizziness
  • nausea and vomiting
  • sweating
• These are not all the possible side effects of epinephrine auto-injector. For more information, ask your doctor or pharmacist.
• You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

SOURCE Lineage Therapeutics Inc.