Sanofi-Aventis U.S. LLC is a healthcare company that discovers, develops, produces, and markets therapeutic solutions focused on patients’ needs in the United States. The company researches, develops, and brings to market healthcare products and treatments for cardiovascular diseases, oncology, sleep disorder, thrombosis, allergy and respiratory illness, diabetes, central nervous system, internal medicine, metabolic disorders, osteoporosis, and hypertension. It offers prescription products, vaccines and biologics, and other products. The company was founded in 1999 and is headquartered in Bridgewater, New Jersey. Sanofi-Aventis U.S. LLC operates as a subsidiary of Sanofi.
55 Corporate Drive
Bridgewater, NJ 08807
Founded in 1999
Sanofi US Issues Voluntary Nationwide Recall of Auvi-Q Due to Potential Inaccurate Dosage Delivery
Oct 28 15
Sanofi US is voluntarily recalling all Auvi-Q (epinephrine injection, USP). The recall involves all Auvi-Q currently on the market and includes both the 0.15 mg and 0.3 mg strengths for hospitals, retailers and consumers. This includes lot number 2299596 through 3037230, which expire March 2016 through December 2016. The products have been found to potentially have inaccurate dosage delivery. If a patient experiencing a serious allergic reaction (i.e., anaphylaxis) did not receive the intended dose, there could be significant health consequences, including death because anaphylaxis is a potentially life-threatening condition. As of October 26, 2015, Sanofi has received 26 reports of suspected device malfunctions in the US and Canada. None of these device malfunction reports have been confirmed. In these reports, patients have described symptoms of the underlying hypersensitivity reaction. No fatal outcomes have been reported among these cases. Auvi-Q (epinephrine injection, USP) is used to treat life-threatening allergic reactions (anaphylaxis) in people who are at risk for or have a history of these reactions. Auvi-Q is packaged with two active devices and one trainer device in a corrugate box. Auvi-Q was distributed throughout the United States via wholesalers, pharmacies and hospitals. All Auvi-Q is being recalled. Sanofi US is notifying its distributors and customers who include doctors, pharmacies, wholesalers and other customers in the supply chain by letter, fax, email and phone calls and is arranging for return and reimbursement of all recalled products.
Sanofi US Announces Launch of Authorized Generic Version of Arava (Leflunomide) Tablets
Oct 1 15
Sanofi US announced the availability of an authorized generic version of Arava, Leflunomide tablets through Winthrop, the company's US generics division. For people living with rheumatoid arthritis (RA), Leflunomide blocks autoimmune antibodies that reduce inflammation with the aim of improving mobility. Sanofi's authorized generic version is the same formulation as the original drug, Arava, for which the company holds the original patent. Rheumatoid arthritis is a chronic disease for which signs and symptoms can be lessened with treatment. Because joint damage is irreversible, early diagnosis and treatment are recommended. Disease-modifying anti-rheumatic drugs (DMARDs) such as Arava help to reduce signs and symptoms, inhibit structural damage as evidenced by X-Ray erosions and joint space narrowing and improve physical function. Since treatment is highly individualized based on patient response, Arava provides the ability to be used either alone or in combination with other DMARDs or biologics. Leflunomide is contraindicated in pregnant women, or women of childbearing potential who are not using reliable contraception. Pregnancy must be excluded before the start of treatment with Leflunomide. Pregnancy must be avoided during Leflunomide treatment and during an accelerated drug elimination procedure after Leflunomide treatment. Leflunomide should be stopped and an accelerated drug elimination procedure should be started if the patient becomes pregnant. Hepatotoxicity: Severe liver injury, including fatal liver failure, has been reported in some patients treated with Leflunomide. Patients with pre-existing acute or chronic liver disease, or those with serum alanine aminotransferase (ALT) >2xULN (upper limit of normal) before initiating treatment, should not be treated with Leflunomide. Use caution when Leflunomide is given with other potentially hepatotoxic drugs. Monitoring of ALT levels is recommended at least monthly for six months after starting Leflunomide, and thereafter every 6-8 weeks. If ALT elevation > 3 fold ULN occurs, interrupt therapy while investigating the probable cause of the ALT elevation by close observation and additional tests. If likely Leflunomide-induced, start cholestyramine washout and monitor liver tests weekly until normalized. If Leflunomide-induced liver injury is unlikely because some other probably cause has been found, resumption of Leflunomide therapy may be considered. Females of childbearing potential: There are no adequate and well-controlled studies evaluating Leflunomide in pregnant women. Thus, do not start Leflunomide until the following steps are completed: Pregnancy is excluded; confirm that reliable contraception is being used; and fully counsel patients on the potential for serious risk to the fetus. If the patient becomes pregnant while taking this drug, the physician and patient must discuss the risk to the pregnancy. Upon discontinuation of Leflunomide, it is recommended that all females of childbearing potential undergo the drug elimination procedure. The patient must be advised that if there is any delay in onset of menses or any other reasons to suspect pregnancy, they must stop Leflunomide and notify the physician immediately for pregnancy testing and if positive, the physician and patient must discuss the risk of pregnancy. It is possible that rapidly lowering the blood level of the active metabolite by instituting the drug elimination procedure described below at the first delay of menses may decrease the risk to the fetus from Leflunomide. Drug elimination procedure for females; Administer cholestyramine 8 grams 3 times daily for 11 days. (The 11 days do not need to be consecutive unless there is a need to lower the plasma level rapidly.) Verify plasma levels less than 0.02 mg/L (0.02 µg/mL) by 2 separate tests at least 14 days apart. If plasma levels are higher than 0.02 mg/L, additional cholestyramine treatment should be considered. Without the drug elimination procedure, it may take up to 2 years for the active metabolite of Leflunomide to reach plasma levels less than 0.02 mg/L due to individual variation in drug clearance. Available information does not suggest that Leflunomide would be associated with an increased risk of male-mediated fetal toxicity. To minimize any possible risk, men wishing to father a child should consider discontinuing use of Leflunomide and taking cholestyramine 8 grams 3 times daily for 11 days. Additional safety information: Leflunomide is contraindicated in patients with known hypersensitivity to Leflunomide, teriflunomide, or any of the other components of Leflunomide. Severe liver injury, including fatal liver failure, has been reported in some patients treated with Leflunomide. Patients with pre-existing acute or chronic liver disease, or those with serum ALT > 2 X ULN before initiating treatment, should not be treated with Leflunomide. Leflunomide is not recommended for patients with severe immunodeficiency, bone marrow dysplasia, or severe, uncontrolled infections. Severe infections including sepsis, which may be fatal, have been reported. Rarely, interstitial lung disease, which may be fatal, has been reported Rare reports of pancytopenia, agranulocytosis, thrombocytopenia, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and peripheral neuropathy have been reported in post marketing experience. In these or any other serious toxicities, Leflunomide should be stopped and a drug elimination procedure (eg, cholestyramine 8 g TID x 11 days) should be used to reduce the drug concentration more rapidly.
ZAI Lab Limited Signs License Agreement with Sanofi-Aventis
Aug 14 14
ZAI Lab Limited has entered into a global licensing agreement with Sanofi-Aventis U.S. LLC for two novel compounds potential treatment of chronic respiratory diseases including chronic obstructive pulmonary disease (COPD), asthma and idiopathic pulmonary fibrosis (IPF). Under the terms of the agreement, ZAI Lab will be responsible for global development, manufacturing and commercialization of the two clinical ready novel programs. Sanofi will potentially receive development and regulatory approval milestones and tiered royalties from the global net sales of the licensed products.