Upsher-Smith Expands Vigadrone^® (vigabatrin) Franchise to Include Tablets

Offers a Fully Substitutable Generic Alternative with Physician, Patient, and Caregiver Support

Maple Grove, MN – August 1, 2023 – 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.

Product Information

Product	Strength	NDC #	Package Size
VIGADRONE® (vigabatrin) Tablets, USP	500 mg	0245-6001-11	bottle 100s

VIGADRONE® (vigabatrin) Tablets are indicated for the treatment of:

• Infantile Spasms (IS) in patients 1 month to 2 years of age, if you and your healthcare provider decide the possible benefits of taking VIGADRONE are more important than the possible risk of vision loss.
• Refractory Complex Partial Seizures (CPS) in adults and children 2 years and older with refractory complex partial seizures (CPS) along with other treatments if:
  • The CPS do not respond well enough to several other treatments, and
  • You and your healthcare provider decide the possible benefit of taking VIGADRONE is more important than the risk of vision loss.

VIGADRONE should not be the first medicine used to treat CPS.

Please see Important Safety Information, including Boxed Warning for Risk of Permanent Vision Loss at the end of this communication.

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)?

WARNING: PERMANENT VISION LOSS See Medication Guide and full Prescribing Information for complete information. All people who take VIGADRONE: You are at risk for permanent vision loss with any amount of VIGADRONE. Your risk of vision loss may be higher the more VIGADRONE you take daily and the longer you take it. It is not possible for your healthcare provider to know when vision loss will happen. It could happen soon after starting VIGADRONE or any time during treatment. It may even happen after treatment has stopped.

• Because VIGADRONE might cause permanent vision loss, it is available to healthcare providers and patients only under a special program called the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program. Your healthcare provider will explain the details of this Program to you.
• VIGADRONE can damage the vision of anyone who takes it. Some people can have severe loss, particularly to their ability to see to the side when looking straight ahead (peripheral vision). With severe vision loss, you may only be able to see things straight in front of you (sometimes called “tunnel vision”). You may also have blurry vision. If this happens, it will not get better.
• Tell your healthcare provider right away if you (or your child): might not be seeing as well as before starting VIGADRONE; start to trip, bump into things, or are more clumsy than usual; are surprised by people or things coming in front of you that seem to come out of nowhere; or if your baby is acting differently than normal. These changes can mean that vision damage has occurred.
• Regular vision testing is recommended. It is recommended that your healthcare provider test your (or your child’s) vision before or within 4 weeks after starting VIGADRONE, and at least every 3 months during treatment until VIGADRONE is stopped. It is also recommended that vision be tested about 3 to 6 months after VIGADRONE is stopped. It is difficult to test vision in babies, but to the extent possible, all patients should have their vision tested. Your healthcare provider will determine if testing can be done. Regular vision testing is important because damage can happen before any changes are noticed.
• Vision tests cannot prevent the vision damage that can happen with VIGADRONE, but they do allow VIGADRONE to be stopped if vision has gotten worse, which usually will lessen further damage. Even these regular vision tests may not show vision damage before it is serious and permanent. Parents, caregivers, and healthcare providers may not recognize the symptoms, or find vision loss in patients, until it is severe.
• If you do not have these vision tests regularly, your healthcare provider may stop prescribing VIGADRONE for you (or your child). Some people are not able to complete vision testing. If vision testing cannot be done, your healthcare provider may continue prescribing VIGADRONE, but will not be able to watch for any vision loss.
• Magnetic resonance imaging (MRI) changes in patients with infantile spasms (IS). Brain pictures taken by MRI show changes in some patients after they are given VIGADRONE. It is not known if these changes are harmful.
• A type of swelling in the brain called intramyelinic edema (IME) has been seen in autopsy examination of patients treated with vigabatrin.
• Risk of suicidal thoughts or actions. Like other antiepileptic drugs, VIGADRONE may cause suicidal thoughts and actions in some people (about 1 in 500 people). Call a healthcare provider right away if you (or your child) have any symptoms, especially sudden changes in mood, behaviors, thoughts or feelings, and especially if they are new, worse, or worry you.
• Do not stop VIGADRONE without first talking to a healthcare provider. Stopping VIGADRONE suddenly can cause seizures that will not stop.

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.

About Upsher-Smith

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 upshersmithstg.wpengine.com.

*Sabril is a registered trademark of Lundbeck.

VIGADRONE is a registered trademark of Upsher-Smith Laboratories, LLC.