FDA Approves Novartis TOBI® Podhaler™ For Certain Cystic Fibrosis Patients, The First And Only Dry Powder Inhaled Antibacterial In US
TOBI Podhaler is anticipated to be available in the US in the second quarter of 2013. Please visit http://www.pharma.us.novartis.com/product/pi/pdf/tobipodhaler.pdf for TOBI Podhaler full Prescribing Information.
ABOUT TOBITOBI ® (tobramycin inhalation solution, USP) 300 mg/5 mL, is a prescription inhaled medication for cystic fibrosis patients whose lungs contain bacteria called Pseudomonas aeruginosa. TOBI has not been studied in patients under six years of age, in those with lung function (FEV 1) outside of a certain range, or in those whose lungs contain bacteria called Burkholderia cepacia.
IMPORTANT SAFETY INFORMATIONIf patients are allergic to antibiotics in the same family as TOBI (i.e., aminoglycosides), they should not take TOBI. They should tell their doctor before starting treatment if they have any history of hearing, kidney, balance, or muscle problems.
Patients taking TOBI may have temporary side effects like coughing or difficulty breathing. Some people taking TOBI experienced ringing in the ears, hearing loss, or changes in voice (hoarseness). Ringing in the ears may be a warning sign for hearing loss. If patients have ringing in the ears, changes in hearing, or dizziness, they should tell their doctor.In studies, kidney damage was not seen in patients taking TOBI. However, antibiotics in the same family as TOBI have been linked to kidney damage. If patients are pregnant, plan to become pregnant, or if they are breast-feeding, they should talk with their doctor before taking TOBI. Some drugs may interact with TOBI. Patients should discuss all medications they are taking with their doctor. Patients with cystic fibrosis can have many symptoms. Some of these may be related to their medications. They should tell their doctor if they have new or worsening symptoms. Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch , or call 1-800-FDA-1088. Please visit www.pharma.us.novartis.com/product/pi/pdf/tobi.pdf for TOBI full Prescribing Information. For more information about cystic fibrosis, please visit www.cff.org. DisclaimerThe foregoing release contains forward-looking statements that can be identified by terminology such as "long-term commitment," "anticipated," or similar expressions, or by express or implied discussions regarding potential future revenues from TOBI Podhaler. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that TOBI Podhaler will achieve any particular levels of revenue. In particular, management's expectations could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; competition in general; government, industry and general public pricing pressures, and unexpected reimbursement decisions; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; unexpected manufacturing issues; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About NovartisNovartis Pharmaceuticals Corporation researches, develops, manufactures and markets innovative prescription drugs used to treat a number of diseases and conditions, including cardiovascular, dermatological, central nervous system, bone disease, cancer, organ transplantation, psychiatry, infectious disease and respiratory. The company's mission is to improve people's lives by pioneering novel healthcare solutions. Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG, which provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion ( USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 128,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com. Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis. For Novartis multimedia content, please visit www.thenewsmarket.com/Novartis. For questions about the site or required registration, please contact: firstname.lastname@example.org. SOURCE Novartis Pharmaceuticals Corporation
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