|View printer-friendly version|
|February 17, 2015 8:30 a.m.|
|Teva Bolsters Injectable Portfolio with Launch of Generic Lovenox® and Generic Zyvox® in the United States|
Teva has also recently launched the generic equivalent to
Zyvox® (linezolid) Injection which is used for the treatment of
infections caused by Gram-positive bacteria. Zyvox® Injection had annual
sales of approximately
“Teva is committed and focused on building a stronger generic injectable
business globally,” said
Teva continues to invigorate the injectable business in
About Enoxaparin Sodium Injection, USP
Enoxaparin Sodium Injection USP, is indicated for:
Important Safety Information
Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture, resulting in long-term or permanent paralysis.
Enoxaparin Sodium Injection, USP is contraindicated in patients with active major bleeding; thrombocytopenia with a positive in vitro test for anti-platelet antibody in the presence of enoxaparin sodium; or known hypersensitivity to enoxaparin sodium, heparin, or pork products. Serious adverse reactions reported with enoxaparin sodium injection include increased risk of hemorrhage and thrombocytopenia. Enoxaparin Sodium Injection, USP should be used with extreme caution in conditions with increased risk of hemorrhage, or in patients treated concomitantly with platelet inhibitors. Major hemorrhages including retroperitoneal and intracranial bleeding have been reported with enoxaparin sodium injection. Some of these cases have been fatal. Bleeding can occur at any site during therapy with Enoxaparin Sodium Injection, USP.
Enoxaparin Sodium Injection, USP should be used with care in patients with a bleeding diathesis, uncontrolled arterial hypertension or a history of recent gastrointestinal ulceration, diabetic retinopathy, renal dysfunction and hemorrhage.
In clinical trials, the most common adverse reactions (> 1% in patients treated with enoxaparin sodium injection) were bleeding, anemia, thrombocytopenia, elevation of serum aminotransferase, diarrhea, and nausea. Mild local irritation, pain, hematoma, ecchymosis, and erythema may follow subcutaneous injection.
Please see accompanying Full Prescribing Information, including Boxed Warning.
About Linezolid Injection
Linezolid Injection is indicated for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia; Community-acquired pneumonia; Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis; Uncomplicated skin and skin structure infections; and Vancomycin-resistant Enterococcus faecium infections. Linezolid Injection is not indicated for the treatment of Gram-negative infections. Gram-negative therapy should be initiated immediately if a concomitant Gram-negative pathogen is documented or suspected.
Important Safety Information
Linezolid Injection is contraindicated in patients with a known hypersensitivity to linezolid or any of the other product components and in patients taking any monoamine oxidase inhibitor (MAOI) or within two weeks of taking an MAOI.
Myelosuppression has been reported in patients receiving linezolid. Complete blood counts should be monitored weekly. Other serious adverse reactions reported with linezolid include peripheral and optic neuropathy; serotonin syndrome, including fatal cases associated with co-administration of linezolid and serotonergic agents; Clostridium difficile associated diarrhea; lactic acidosis; convulsions; hypoglycemia; and development of drug-resistant bacteria.
Unless patients are monitored for potential increases in blood pressure, linezolid should not be administered to patients with uncontrolled hypertension, pheochromocytoma, thyrotoxicosis and/or patients taking sympathomimetic, vasopressive, or dopaminergic agents.
In clinical trials, the most common adverse reactions (>5% of adult and/or pediatric patients treated with linezolid) were diarrhea, vomiting, headache, nausea, and anemia.
Please see accompanying Full Prescribing Information.
About Chemi SPA
Chemi SPA is an Italian fine chemical and pharmaceutical company,
Cautionary Notice Regarding Forward-Looking Statements
This release contains forward-looking statements, which are based on
management’s current beliefs and expectations and involve a number of
known and unknown risks and uncertainties that could cause our future
results, performance or achievements to differ significantly from the
results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to: our ability to
develop and commercialize additional pharmaceutical products;
competition for our innovative products, especially Copaxone®
(including competition from orally-administered alternatives, as well as
from potential purported generic equivalents) and our ability to migrate
users to our new 40 mg/mL version; the possibility of material fines,
penalties and other sanctions and other adverse consequences arising out
of our ongoing FCPA investigations and related matters; our ability to
achieve expected results from the research and development efforts
invested in our pipeline of specialty and other products; our ability to
reduce operating expenses to the extent and during the timeframe
intended by our cost reduction program; our ability to identify and
successfully bid for suitable acquisition targets or licensing
opportunities, or to consummate and integrate acquisitions; the extent
to which any manufacturing or quality control problems damage our
reputation for quality production and require costly remediation;
increased government scrutiny in both the U.S. and
Teva Pharmaceutical Industries Ltd.