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AVYCAZ is an antibiotic developed to treat certain serious Gram-negative bacterial infections. It consists of ceftazidime, a third-generation cephalosporin and an established and respected treatment for serious Gram-negative bacterial infections, and avibactam, a non-β lactam β-lactamase inhibitor.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of AVYCAZ and other antibacterial drugs, AVYCAZ should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.
AVYCAZ is contraindicated in patients with known serious hypersensitivity to the components of AVYCAZ (ceftazidime and avibactam), avibactam‑containing products, or other members of the cephalosporin class.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of DALVANCE and other antibacterial agents, DALVANCE should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.
DALVANCE is contraindicated in patients with known hypersensitivity to dalbavancin.
Serious hypersensitivity (anaphylactic) and skin reactions have been reported with glycopeptide antibacterial agents, including DALVANCE. Exercise caution in patients with known hypersensitivity to glycopeptides due to the possibility of cross-sensitivity. If an allergic reaction occurs, treatment with DALVANCE should be discontinued.
Rapid intravenous infusion of DALVANCE can cause reactions, including flushing of the upper body, urticaria, pruritus, and rash.
ALT elevations with DALVANCE treatment were reported in clinical trials.
Prescribing DALVANCE in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
The most common adverse reactions in patients treated with DALVANCE were nausea (4.7%), headache (3.8%), and diarrhea (3.4%).
Allergan plc(formerlyForest Laboratories) obtained the worldwide rights (excludingJapan, whereTakeda Pharmaceuticalsholds rights) to TEFLARO in 2007 when it acquiredCerexa, Inc., a privately held biopharmaceutical company. InAugust 2009,Forest Laboratories and AstraZenecaentered into a definitive collaboration agreement to co-develop and commercialize ceftaroline fosamil in all markets outside the U.S.,CanadaandJapan.
Allerganmarkets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women’s health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world’s third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines.Allerganis an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.
With commercial operations in approximately 100 countries,Allerganis committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflectAllergan’scurrent perspective of existing trends and information as of the date of this release. Except as expressly required by law,Allergandisclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially fromAllergan’scurrent expectations depending upon a number of factors affectingAllergan’sbusiness. These factors include, among others, the difficulty of predicting the timing or outcome ofFDAapprovals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan’sproducts; difficulties or delays in manufacturing; and other risks and uncertainties detailed inAllergan’speriodic public filings with theSecurities and Exchange Commission, including but not limited toAllergan’sAnnual Report on Form 10-K for the year endedMarch 31, 2016 (certain of such periodic public filings having been filed under the “Actavis plc” name). Except as expressly required by law,Allergandisclaims any intent or obligation to update these forward-looking statements.
SOURCE Allergan plc