Subject: FDA
FDA Approves New Manufacturing Facility in Clearwater, Florida for Sacrosidase, Active Ingredient of Sucraid® (sacrosidase) Oral Solution, for the Treatment of Congenital Sucrase-Isomaltase Deficiency
VERO BEACH, Fla., Oct. 2, 2018 /PRNewswire/ -- Today QOL Medical, LLC announced that the U.S. Food and Drug Administration (FDA) has approved the company's wholly owned manufacturing facility in Clearwater, Florida to manufacture sacrosidase, the drug substance used to make Sucraid® (sacrosidase) Oral Solution.
The Sucraid® drug shortage has been resolved, and this FDA approval eliminates the need for informed consents, assents, physician acknowledgments, and patient questionnaires for all Sucraid® prescriptions. Sucraid® is now available as a regular prescription exclusively from US Bioservices. Please call 1-833-800-0122 for further information.
The long-term supply of Sucraid® continues to be QOL Medical's top priority. QOL Medical has developed an improved manufacturing process for sacrosidase production, designed and built a wholly owned cGMP-compliant manufacturing facility, and hired an experienced manufacturing and quality team to assure this goal.
About Sucraid®
Sucraid® (sacrosidase) Oral Solution is an enzyme replacement therapy for the treatment of genetically determined sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID). Sucraid® can help improve the breakdown and absorption of sucrose (table sugar) from the intestine and can help relieve the gastrointestinal symptoms of CSID.
INDICATION
Sucraid® (sacrosidase) Oral Solution is an enzyme replacement therapy for the treatment of genetically determined sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID).
IMPORTANT SAFETY INFORMATION FOR SUCRAID® (SACROSIDASE) ORAL SOLUTION
- Sucraid® may cause a serious allergic reaction. If you notice any swelling or have difficulty breathing, get emergency help right away.
- Sucraid® does not break down some sugars that come from the digestion of starch. You may need to restrict the amount of starch in your diet. Your doctor will tell you if you should restrict starch in your diet.
- Tell your doctor if you are allergic to, have ever had a reaction to, or have ever had difficulty taking yeast, yeast products, papain, or glycerin (glycerol).
- Tell your doctor if you have diabetes, as your blood glucose levels may change if you begin taking Sucraid®. Your doctor will tell you if your diet or diabetes medicines need to be changed.
- Some patients may have worse abdominal pain, vomiting, nausea, or diarrhea. Constipation, difficulty sleeping, headache, nervousness, and dehydration have also occurred. Check with your doctor if you notice these or other side effects.
- Sucraid® has not been tested to see if it works in patients with secondary (acquired) sucrase deficiency.
- NEVER HEAT SUCRAID® OR PUT IT IN WARM OR HOT BEVERAGES OR INFANT FORMULA. Do not mix Sucraid® with fruit juice or take it with fruit juice. Take Sucraid® as prescribed by your doctor. Normally half of the dose of Sucraid® is taken before a meal or snack and the other half is taken during the meal or snack.
- Sucraid® should be refrigerated at 36°F-46°F (2°C-8°C) and should be protected from heat and light.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
Click here for Sucraid® full prescribing information.
About CSID
CSID is a genetic disease caused by mutations in the sucrase-isomaltase gene that result in a reduction or total absence of sucrase activity and variable isomaltase and maltase activity. Patients with CSID often experience watery diarrhea due to the osmotic effect of malabsorbed sugars as well as gas, bloating, and abdominal pain caused by bacterial fermentation of undigested sucrose which releases methane and hydrogen in the colon. Presentation of CSID in adolescents and adults has been characterized by symptoms of postprandial dyspepsia, gas, loose stools, and diarrhea overlapping with common irritable bowel syndrome (IBS) symptoms. In infants, CSID classically presents as explosive watery diarrhea, failure to thrive, diaper rash, irritability, and acidic stools.
About QOL Medical, LLC
QOL Medical is a specialty biopharmaceutical company dedicated to improving clinical outcomes and overall quality of life for patients with rare diseases. QOL Medical is a patient-centric company founded in 2003 to focus on the acquisition and commercialization of orphan and gastrointestinal products in underserved markets. Learn more at www.qolmed.com.
Sucraid® is a registered trademark of QOL Medical, LLC. All rights reserved.
Media Contact:
QOL Medical, LLC
Tiffany Carter
Phone: 818-720-8557
Email: [email protected]
Corporate Contact:
QOL Medical, LLC
3405 Ocean Drive
Vero Beach, FL 32963
Phone: 866-469-3773
Fax: 772-365-3375
Email: [email protected]
Specialty Pharmacy:
US Bioservices
Phone: 833-800-0122
https://www.usbioservices.com/contact-us
SOURCE QOL Medical, LLC
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