A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Subscribe to Drugs.com newsletters for the latest medication news, alerts, new drug approvals and more. Veletri is commercially available in 17 markets, including the US since 2010, Switzerland and Canada (marketed as Caripul®) since 2012, Japan (marketed as Epoprostenol “ACT”) since 2013, and some European countries since 2013. ZAVESCA (miglustat - capsule;oral) Manufacturer: ACTELION PHARMS LTD Approval date: July 31, 2003 Strength(s): 100MG [] []; Has a generic version of Zavesca been approved? Available for Android and iOS devices. Ask your health care provider for advice if you are unsure about the online purchase of any medication. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. recommendations. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. This Zavesca price guide is based on using the Drugs.com discount card which is accepted at most U.S. pharmacies. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against. You and your doctor should decide if you will breastfeed or take ZAVESCA. Perform neurological evaluations at baseline, then periodically at 6-month intervals. Moderate renal impairment (CrCl 30–50mL/min): 100mg once daily. Zavesca is a brand name of miglustat, approved by the FDA in the following formulation(s):. ZAVESCA ® can make a difference when used alone to treat adults who have mild to moderate type 1 Gaucher disease.. Clinical studies have shown that ZAVESCA ® may be used alone to treat adults with mild to moderate type 1 Gaucher disease in people who cannot be treated with enzyme replacement therapy.. Changes in your diet can make a difference as your body adjusts to ZAVESCA ® therapy. Nursing mothers: not recommended. You may report side effects to FDA at 1-800-FDA-1088. Mild to moderate type 1 Gaucher disease when enzyme replacement therapy is not feasible. Zavesca Cares support for people taking ZAVESCA. Take ZAVESCA exactly as your doctor has prescribed. Copyright © 2020 Haymarket Media, Inc. All Rights Reserved A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). Miglustat is a drug used to treat Gaucher disease. Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Data sources include IBM Watson Micromedex (updated 1 Oct 2020), Cerner Multum™ (updated 1 Oct 2020), Wolters Kluwer™ (updated 30 Sep 2020) and others. Eligible patients will pay no more than a $10 dollar co-pay for their ZAVESCA (miglustat) therapy—up to 13 uses each calendar year. Labor & delivery. ZAVESCA is not available at your local pharmacy. Tell your doctor if you have any side effect that bothers you or that does not go away. For more information, ask your doctor or pharmacist. These medications may be counterfeit and potentially unsafe. 1 Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. GI disease (eg, inflammatory bowel). Download, Zavesca Cares™ support for people taking ZAVESCA® (miglustat). Numbness, tingling, pain, or burning of your skin. You should not do both. Call your doctor for medical advice about side effects. www.gaucherdisease.org ZAVESCA patient support is provided by Actelion Pharmaceuticals US, Inc., the company that makes ZAVESCA, and by Accredo, a specialty pharmacy that ensures patients have continued access to their medication. 1-800-504-3189. Select one or more newsletters to continue. Patients must agree to the Terms and Conditions (click here to view). Use of Zavesca in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m. 2) is not recommended. It was developed by Oxford GlycoSciences and is marketed by Actelion. Reevaluate and consider discontinuation if signs/symptoms of peripheral neuropathy develop (eg, numbness, tingling). Severe renal impairment: not recommended. Select any of the links below to download information about type 1 Gaucher disease, ZAVESCA therapy, and healthy dietary choices that can help with this condition. Zavesca (miglustat) reduces the formation of a certain protein in the body in people with type 1 Gaucher disease. Mild renal impairment (CrCl 50–70mL/min): 100mg twice daily. ZAVESCA patient support is provided by Actelion Pharmaceuticals US, Inc., the company that makes ZAVESCA, and by Accredo, a specialty pharmacy that ensures patients have continued access to … Learn more about our Products. This material may not be published, broadcast, rewritten or redistributed in any form without prior authorization. Approved by the FDA in the following formulation ( s ): 100mg daily! Page applies to your personal circumstances about all the medicines you take, including prescription and sizes. Disease when enzyme replacement therapy with imiglucerase own personal medication records < 30 ml/min/1.73 m. 2 ) not... 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