Benzinga | Jun 22, 2021 05:19PM EDT

Teva Announces Its Launch Of Generic PERFOROMIST, Formoterol Fumarate Inhalation Solution, 20 mcg/2 ML, Used To Treat Chronic Obstructive Pulmonary Disease (COPD), In The U.S.

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced its U.S. launch of the first generic version of twice daily PERFOROMIST(r),formoterol fumarate inhalation solution, 20 mcg/2 ML, indicated to treat bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

"Teva is pleased to provide patients with first-to-market access to a generic version of PERFOROMIST(r) (formoterol fumarate inhalation solution)," said Christine Baeder, SVP, Chief Operating Officer US Generics, Teva USA.

With over 500 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market and holds the leading position in first-to-file opportunities, with more than 100 pending first-to-files in the U.S. Currently, 1 in 11 generic prescriptions dispensed in the U.S. is filled with a Teva generic product.

PERFOROMIST(r)(formoterol fumarate inhalation solution) has annual sales of more than $299 million in the U.S., according to IQVIA data as of March 2021.

About Formoterol Fumarate Inhalation Solution, 20 mcg/2 ML

* Formoterol fumarate inhalation solution is a long-acting beta2 adrenergic agonist (LABA) used to control the symptoms of COPD in adults with COPD. COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.

* Formoterol fumarate inhalation solution is only for use with a nebulizer.

* LABA medicines such as formoterol fumarate inhalation solution help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath.

* Formoterol fumarate inhalation solution is for long-term use and should be taken 2 times each day, to improve the symptoms of COPD for better breathing.

* Formoterol fumarate inhalation solution is not used to treat sudden symptoms of COPD.

* Formoterol fumarate inhalation solution is not for the treatment of asthma. It is not known if formoterol fumarate inhalation solution is safe and effective in people with asthma.

Formoterol fumarate inhalation solution should not be used in children. It is not known if formoterol fumarate inhalation solution is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Do not use formoterol fumarate inhalation solution if you have asthma.

Before using formoterol fumarate inhalation solution tell your healthcare provider about all of your medical conditions, including if you:

* have heart problems

* have high blood pressure

* have diabetes

* have seizures

* have thyroid problems

* have liver problems

* are pregnant or plan to become pregnant. It is not known if the medicine formoterol in formoterol fumarate inhalation solution passes into breast milk and if it can harm your baby.

* are breastfeeding or plan to breastfeed. It is not known if the medicine formoterol in formoterol fumarate inhalation solution passes into breast milk and if it can harm your baby.

Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins and herbal supplements. Formoterol fumarate inhalation solution and certain other medicines may interact with each other. This may cause serious side effects.

What are the possible side effects of formoterol fumarate inhalation solution?

Formoterol fumarate inhalation solution can cause serious side effects, including:

* people with asthma who take long-acting LABA medicines, such as formoterol fumarate inhalation solution, without also using a medicine called an inhaled corticosteroid, have an increased risk of serious problems from asthma, including being hospitalized, needing a tube placed in their airway to help them breathe, or death. Call your healthcare provider if breathing problems worsen over time while using formoterol fumarate inhalation solution. You may need a different treatment. Get emergency medical care if: breathing problems worsen quickly you use your rescue inhaler medicine, but it does not relieve your breathing problems

* COPD symptoms that get worse over time. If your COPD symptoms worsen over time, do not increase your dose of formoterol fumarate inhalation solution, instead call your healthcare provider.

* using too much of a LABA medicine may cause: chest pain, fast and irregular heartbeat, tremor, increased blood pressure, headache, or nervousness.

* sudden shortness of breath immediately after use of formoterol fumarate inhalation solution. Sudden shortness of breath may be life-threatening. If you have sudden breathing problems immediately after inhaling your medicine, call your healthcare provider or go to nearest hospital emergency room right away.

* effects on your heart, including fast or irregular heartbeat, chest pain or increased blood pressure.

* changes in laboratory levels, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia), which may cause symptoms of muscle spasm, muscle weakness or abnormal heart rhythm.

* serious allergic reactions including rash, hives, swelling of the face, mouth, and tongue, and breathing problems. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction.

Common side effects of formoterol fumarate inhalation solution include: headache, muscle cramps, dizziness, tremor, nausea, tiredness, nervousness, vomiting, trouble sleeping, dry mouth, or diarrhea.

Tell your healthcare provider if you get any side effect that bothers you or that does not go away. These are not all the possible side effects of formoterol fumarate inhalation solution. For more information, ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information, please see accompanying full Prescribing Information. A copy may be requested from Teva U.S. Medical Information at 888-TEVA-USA (888-838 2872), druginfo@tevapharm.com, or Teva's Public Relations or Investor Relations contacts.