Teva Announces Launch of its Generic Erythromycin Tablets USP, Used to Treat or Prevent a Variety of Bacterial Infections, in the United States

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TEL AVIV, Israel & PARSIPPANY, N.J.–()–Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced the launch of its 250 mg and 500 mg strength generic Erythromycin tablets—a therapeutic equivalent for the reference listed drug (RLD) Erythromycin Tablets from Arbor Pharmaceuticals. Teva generic Erythromycin tablets are indicated to treat a variety of bacterial infections, and to prevent initial or recurrent attacks of rheumatic fever in patients allergic to penicillin.

With nearly 550 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 approximately 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.

Erythromycin oral tablets has annual sales of more than $49 million in the U.S., according to IQVIA data as of January 2021.

About Erythromycin Tablets

Erythromycin tablets are a prescription antibiotic medication used in the treatment of infections caused by specific, susceptible strains of microorganisms in the following diseases: respiratory tract infections; listeriosis; skin and skin structure infections; pertussis (whooping cough); diphtheria; erythrasma; intestinal amebiasis; acute pelvic inflammatory disease; conjunctivitis in newborns; pneumonia of infancy; urogenital infections during pregnancy; uncomplicated urethral, endocervical, or rectal infections in adults in specific situations; nongonococcal urethritis in specific situations; primary syphilis; and Legionnaires’ Disease.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about erythromycin tablets?

Erythromycin tablets should not be used if you have a known hypersensitivity to this antibiotic or if you are taking terfenadine, astemizole, cisapride, pimozide, ergotamine, or dihydroergotamine. If you are unsure, ask your doctor if you are taking any of these medications.

Erythromycin tablets should not be taken together with certain statins including lovastatin or simvastatin. Talk to your doctor if you are currently taking statins to help control your cholesterol.

Erythromycin tablets can cause liver problems including increased liver enzymes; and certain types of hepatitis, with or without jaundice.

Erythromycin tablets can cause problems with your heart and heart rate resulting in death. Erythromycin tablets should be avoided in patients with heart or heart rate problems, and/or are taking medications to treat these conditions. Elderly patients may have a higher risk of drug-associated effects on the heart and heart rate. Tell your doctor about all medications you take including prescription and over-the-counter medicines, vitamins and herbal supplements.

Erythromycin tablets should not be used to prevent syphilis in infants born to women treated during pregnancy with oral erythromycin.

Erythromycin tablets may cause a condition called Clostridium difficile associated diarrhea (CDAD). The condition can range in severity from mild diarrhea to fatal inflammation of the colon.

Erythromycin tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). Although it is common to feel better early in the course of taking erythromycin tablets, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by erythromycin tablets or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, contact your doctor as soon as possible.

What should I tell my doctor before taking erythromycin tablets?

Tell your doctor about all medications you take including prescription and over-the-counter medicines, vitamins and herbal supplements. Serious side effects can occur when taking erythromycin tablets with other medications.

What are the possible side effects of erythromycin tablets?

The most frequent side effects of erythromycin tablets are nausea, vomiting, abdominal pain, diarrhea and anorexia. Symptoms of hepatitis, liver dysfunction and/or abnormal liver function test results may occur.

Inflammation of the colon (colitis) may occur during or after antibacterial treatment.

Erythromycin tablets have been associated with heart problems and heart rate problems which can be fatal.

Allergic reactions ranging from a rash to severe life-threatening allergic reactions have occurred. Skin reactions ranging from mild to severe have been reported rarely.

There have been reports of kidney disorder with erythromycin tablets.

There have been rare reports of inflammation of the pancreas and convulsions.

There have been isolated reports of reversible hearing loss occurring chiefly in patients with poor kidney function and in patients receiving high doses of erythromycin.

These are not all the possible side effects of erythromycin tablets.

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.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the launch of our 250 mg and 500 mg strength generic Erythromycin tablets in the United States, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:

  • the commercial success of our 250 mg and 500 mg strength generic Erythromycin tablets;
  • our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; consolidation of our customer base and commercial alliances among our customers; delays in launches of new generic products; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; our ability to develop and commercialize biopharmaceutical products; competition for our specialty products, including AUSTEDO®, AJOVY® and COPAXONE®; our ability to achieve expected results from investments in our product pipeline; our ability to develop and commercialize additional pharmaceutical products; and the effectiveness of our patents and other measures to protect our intellectual property rights;
  • our substantial indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, may result in a further downgrade of our credit ratings; and our inability to raise debt or borrow funds in amounts or on terms that are favorable to us;
  • our business and operations in general, including: uncertainty regarding the magnitude, duration, and geographic reach of the COVID-19 pandemic and its impact on our business, financial condition, operations, cash flows, and liquidity and on the economy in general; our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the COVID-19 pandemic and associated costs therewith; effectiveness of our optimization efforts; our ability to attract, hire and retain highly skilled personnel; manufacturing or quality control problems; interruptions in our supply chain; disruptions of information technology systems; breaches of our data security; variations in intellectual property laws; challenges associated with conducting business globally, including political or economic instability, major hostilities or terrorism; costs and delays resulting from the extensive pharmaceutical regulation to which we are subject or delays in governmental processing time due to travel and work restrictions caused by the COVID-19 pandemic; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; significant sales to a limited number of customers; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; and our prospects and opportunities for growth if we sell assets;
  • compliance, regulatory and litigation matters, including: failure to comply with complex legal and regulatory environments; increased legal and regulatory action in connection with public concern over the abuse of opioid medications and our ability to reach a final resolution of the remaining opioid-related litigation; scrutiny from competition and pricing authorities around the world, including our ability to successfully defend against the U.S. Department of Justice criminal charges of Sherman Act violations; potential liability for patent infringement; product liability claims; failure to comply with complex Medicare and Medicaid reporting and payment obligations; compliance with anti-corruption sanctions and trade control laws; and environmental risks;
  • other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our intangible assets; potential significant increases in tax liabilities; and the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business;

and other factors discussed in this press release and in our Annual Report on Form 10-K for the year ended December 31, 2020, including in the sections captioned “Risk Factors” and “Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.



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