Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the recent launch of VIGADRONE® (vigabatrin) Tablets, USP 500 mg, a fully substitutable, AB-rated generic version of Sabril® (vigabatrin) Tablets, 500 mg.* The Company also offers VIGADRONE® (vigabatrin) for Oral Solution, USP 500 mg.
"Upsher-Smith is always looking for innovative and impactful ways to make prescribing our products easier for physicians and more accessible to patients," said Rich Fisher, President and COO, Upsher-Smith. "We understand the challenges associated with prescribing and accessing specialty drugs, particularly vigabatrin, and our team is committed to providing service and support that helps give peace of mind to our providers and patients."
To learn more about the VIGADRONE® family of products and Upsher-Smith's support program, visit vigadrone.com.
VIGADRONE® (vigabatrin) Tablets are indicated for the treatment of:
VIGADRONE should not be the first medicine used to treat CPS.
Vigabatrin REMS Program
The U.S. FDA has approved a single shared system Risk Evaluation and Mitigation Strategy (REMS) for all vigabatrin products called the Vigabatrin REMS Program. It is required by the FDA to ensure informed risk-benefit decisions before initiating treatment and to ensure appropriate use of vigabatrin while patients are treated.
Healthcare providers must be certified in the Vigabatrin REMS Program to prescribe VIGADRONE® and patients must be enrolled in the Vigabatrin REMS Program to receive VIGADRONE®. All certified prescribers and enrolled patients in the Sabril® REMS Program have been transitioned to the Vigabatrin REMS Program and do not need to recertify or re-enroll.
WHAT IMPORTANT SAFETY INFORMATION SHOULD I KNOW ABOUT VIGADRONE® (vigabatrin)?
VIGADRONE can cause serious side effects such as low red blood cell counts (anemia), sleepiness and tiredness, nerve problems, weight gain, and swelling. Because VIGADRONE causes sleepiness and tiredness, do not drive, operate machinery, or perform any hazardous task, unless it is decided that these things can be done safely. VIGADRONE may make certain types of seizures worse. Tell your healthcare provider right away if seizures get worse.
Before starting VIGADRONE, tell your doctor about all of your (or your child's) medical conditions including depression, mood problems, suicidal thoughts or behavior, any allergic reaction to VIGADRONE, vision problems, kidney problems, low red blood cell counts (anemia), and any nervous or mental illnesses. Tell your doctor about all the medicines you (or your child) take.
If you are breastfeeding or plan to breastfeed, VIGADRONE can pass into breast milk and may harm your baby. Breastfeeding is not recommended.
If you are pregnant or plan to become pregnant, VIGADRONE can cause harm to your unborn baby. You and your healthcare provider will have to decide if you should take VIGADRONE while you are pregnant.
The most common side effects of VIGADRONE in adults include: blurred vision, sleepiness, dizziness, problems walking or feeling uncoordinated, shaking (tremor) and tiredness.
The most common side effect of VIGADRONE in children 3 to 16 years of age is weight gain. Also expect side effects like those seen in adults.
The most common side effects of VIGADRONE in babies include: sleepiness (sleepy babies may have a harder time suckling and feeding or may be irritable), swelling in the bronchial tubes (bronchitis), ear infection and irritability.
Tell your healthcare provider if you or your child have any side effect that bothers you or that does not go away.
This is the most important information to know about VIGADRONE, but it is not all the safety information. For more information, ask your healthcare provider or pharmacist, or please see the VIGADRONE Medication Guide, full Prescribing Information including Boxed Warning for risk of permanent vision loss, and Instructions for Use. You can also visit vigadrone.com, upsher-smith.com or call 1-888-650-3789.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-332-1088.
Upsher-Smith Laboratories, LLC is a trusted U.S. pharmaceutical company that strives to improve the health and lives of patients through an unwavering commitment to high-quality products and sustainable growth. The company brings brands and generics to a wide array of customers, always backed by its attentive level of service, strong industry relationships, and dedication to uninterrupted supply. For more information, visit www.upsher-smith.com.
*Sabril is a registered trademark of Lundbeck.
VIGADRONE is a registered trademark of Upsher-Smith Laboratories, LLC.
SOURCE Upsher-Smith Laboratories, LLC