Visit Upsher-Smith at the PPMD 2025 Annual Conference Resource Fair to Learn More About Support Services and Resources Offered for Deflazacort Tablets
MAPLE GROVE, Minn., June 16, 2025 -- Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced its participation at the Parent Project Muscular Dystrophy (PPMD) 2025 Annual Conference from June 19-21, 2025 in Las Vegas, Nevada. Representatives from Upsher-Smith will be available to share information about Deflazacort Tablets and discuss the Company's intent and commitment to bring its best-in-class rare disease support and services to the Duchenne muscular dystrophy community.
"Experience matters in rare disease. Founded in 1919, Upsher-Smith has been serving patients for more than 100 years and has a long-standing commitment to supporting the unique needs of rare disease communities," said Jim Maahs, Head of Commercial, Upsher-Smith. "As a trusted partner in pediatric rare disease, we invite attendees to visit us during this year's PPMD Annual Conference to learn how Upsher-Smith is committing to elevating the standard of support for patients and families affected by Duchenne muscular dystrophy (DMD) by offering high-quality generic treatment options that match or exceed the level of support services provided by innovator brands."
About Upsher-Smith's Deflazacort Tablets
Deflazacort Tablets from Upsher-Smith are an AB-rated generic version of Emflaza® (deflazacort) Tablets.1 This means they have the same active ingredient in the same strength and dosage form and provide the same efficacy, tolerability, and safety as Emflaza®.1 Deflazacort Tablets are indicated for the treatment of DMD in patients 5 years of age and older. Upsher-Smith's Deflazacort Tablets are available in 6 mg, 18 mg, 30 mg and 36 mg strengths. Deflazacort tablets are manufactured by Upsher-Smith in Minnesota.
INDICATION & IMPORTANT SAFETY INFORMATION FOR DEFLAZACORT TABLETS
INDICATION
DEFLAZACORT TABLETS are a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older.
IMPORTANT SAFETY INFORMATION
Contraindications: DEFLAZACORT TABLETS are contraindicated in patients with a hypersensitivity to deflazacort or any of the inactive ingredients.
Warnings & Precautions
- Alterations in Endocrine Function: Corticosteroids, such as DEFLAZACORT, can cause serious and life-threatening alterations in endocrine function, especially with chronic use. Monitor patients receiving DEFLAZACORT for Cushing's syndrome, hyperglycemia, and adrenal insufficiency after DEFLAZACORT withdrawal. In addition, patients with hypopituitarism, primary adrenal insufficiency or congenital adrenal hyperplasia, altered thyroid function, or pheochromocytoma may be at increased risk for adverse endocrine events. Acute adrenal insufficiency or "withdrawal syndrome" can occur if corticosteroids are withdrawn abruptly and can be fatal. The risk is reduced by gradually tapering the corticosteroid dose when withdrawing treatment. During times of medical stress, corticosteroid dosage may need to be increased.
- Immunosuppression and Increased Risk of Infection: Increased risk of new, exacerbation, dissemination, or reactivation of latent infections, which can be severe and at times fatal; signs and symptoms of infection may be masked. Monitor for the development of infection and consider DEFLAZACORT withdrawal or dosage reduction as needed. Tell patients and/or caregivers to inform their healthcare provider if the patient has had recent or ongoing infections or if they have recently received a vaccine. Warn patients who are on corticosteroids who have not had chickenpox or measles to avoid exposure to chickenpox or measles and to alert their healthcare provider immediately if they are exposed.
- Alterations in Cardiovascular/Renal Function: Monitor for elevated blood pressure. Dietary salt restriction and potassium supplementation may be necessary. DEFLAZACORT should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency.
- Gastrointestinal Perforation: Increased risk of gastrointestinal perforation during corticosteroid use in patients with certain gastrointestinal disorders such as active or latent peptic ulcers, diverticulitis, recent intestinal anastomoses, and inflammatory bowel disease. Signs and symptoms may be masked.
- Behavioral and Mood Disturbances: May include euphoria, insomnia, mood swings, personality changes, severe depression, and psychosis. Symptoms typically emerge within a few days or weeks of starting treatment and may be dose-related. Inform patients or caregivers of the potential for behavioral and mood changes.
- Effects on Bones: The risk of osteoporosis increases with prolonged use of DEFLAZACORT, which can predispose patients to vertebral and long bone fractures. Monitor for decreases in bone density with chronic use of DEFLAZACORT. Encourage patients to seek medical attention if symptoms develop or worsen.
- Ophthalmic Effects: May include cataract formation, ocular infections, and glaucoma. If treatment with corticosteroids, including DEFLAZACORT, are continued for more than 6 weeks, monitor intraocular pressure.
- Vaccination: Do not administer live or live attenuated vaccines to patients receiving immunosuppressive doses of corticosteroids. Administer live-attenuated or live vaccines at least 4 to 6 weeks prior to starting DEFLAZACORT.
- Serious Skin Rashes: Toxic epidermal necrolysis has been reported with the use of deflazacort. Discontinue at the first sign of rash, unless the rash is clearly not drug related.
- Effects on Growth and Development: Long-term use of corticosteroids, including DEFLAZACORT, can have negative effects on growth and development in children.
- Thromboembolic Events: Observational studies have shown an increased risk of thromboembolism. Use DEFLAZACORT with caution in patients who have or may be predisposed to thromboembolic disorders.
Adverse Reactions: The most common adverse reactions (≥10% for DEFLAZACORT and greater than placebo) are Cushingoid appearance, weight increased, increased appetite, upper respiratory tract infection, cough, pollakiuria, hirsutism, central obesity, and nasopharyngitis.
Drug Interactions: Give one third of the recommended dose of DEFLAZACORT when DEFLAZACORT is administered with strong or moderate CYP3A4 inhibitors. Avoid use of strong or moderate CYP3A4 inducers with DEFLAZACORT, as they may reduce efficacy.
This safety information is not comprehensive.
Please see the full Prescribing Information for DEFLAZACORT TABLETS. You can also visit www.upsher-smith.com or call 1-888-650-3789.
You are encouraged to report suspected adverse reactions to Upsher-Smith Laboratories, LLC at 1-888-650-3789 or to the FDA by visiting www.fda.gov/medwatch.
About Upsher-Smith
Upsher-Smith Laboratories, LLC, now a member of Bora Group, 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. We bring generics and brands to a wide array of customers, always backed by our attentive level of service, strong industry relationships, and dedication to uninterrupted supply. For more information, visit www.upsher-smith.com.
About Bora
Founded in 2007, Bora Pharmaceutical Co., Ltd. ("Bora" or "the Company", 6472.TW) now is the largest pharmaceutical manufacturer in Taiwan with well-connected global distribution to supply more than 100 countries around the world. Bora is dedicated to becoming a global leader in pharmaceutical manufacturing by offering its clients the best quality, efficiency and reliability. For more information, visit www.bora-corp.com.
Reference:
1. Approved Drug Products with Therapeutic Equivalence Evaluations | Orange Book Food and Drug Administration Website. https://www.accessdata.fda. gov/scripts/cder/ob/index.cfm.
Emflaza is a registered trademark of PTC Therapeutics, Inc.
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