FDA Approves New Indication for Budesonide

FDA Approves New Indication for Budesonide

On January 15, 2013 Santarus, Inc. announced that the FDA had approved Budesonide, as the brand name Ulceris, for the induction of remission in patients with mild, moderate and active forms of ulcerative colitis. As an extended release tablet, this new indication approval of budesonide is a vital and novel therapeutic option for patients. Adult dosage of budesonide for active, moderate or mild ulcerative colitis is approved at one 9 milligram tablet, to be taken one time daily, preferably in the morning, for up to eight weeks.  Patients suffering from this gastrointestinal disease will find great relief from acute symptoms, such as bloating, diarrhea, cramping, weight loss and extreme fatigue.

ulcerative colitis

Budesonide is already an apt and cogent treatment option in the form of a nasal spray. Known as the brand name Rhinocort Aqua, the patent for this puissant medication will expire on April 29, 2017. As a nasal spray budesonide also contains a corticosteroid, and works by preventing the release of substances in the body that cause inflammation. Indicated for the treatment of symptoms caused by seasonal or year-round allergies, such as sneezing, a runny or stuffy nose and congestion, budesonide may also be prescribed to keep nasal polyps from coming back after surgery to remove them. Additionally, Rhinocort (budesonide and corticosteroid) have also been used to help patients who are in remission with Crohn’s disease remain in remission, and to aid asthma patients with controlling their symptoms. Adverse effects of budesonide (Rhinocort) are few, and may include a mild sore throat, dry throat or irritation in the nasal passages. LGM Pharma offers API Budesonide CAS# 51333-22-3 for research and development purposes. Clients can be assured of quality products and continuous support throughout the R&D process.


The therapeutic efficacy has been evaluated for Rhinocort Aqua (budesonide) in a number of studies, and results have been favorable. One particular study, which involved 691 males and 694 females ages 12 and older, also evaluated the pediatric population, with 90 males and 51 females aged 6-12 years. This placebo-controlled clinical trial took place between 3 and 6 weeks, and involved mostly Caucasian patients with seasonal and perennial allergic rhinitis. Results from this study indicated that an administration of one spray daily in each nostril of budesonide (Rhinocort) Nasal Spray statistically reduced the severity of nasal symptoms of seasonal and perennial allergic rhinitis in patients significantly. Symptoms like a runny nose, sneezing, and nasal congestion were all deemed greatly improved by participants in this study, with the majority of patients noting relief within 10 hours of using the first dose. It is important to note that the maximum benefit of this nasal spray may not be achieved until approximately 2 weeks after the initiation of treatment.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

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LGM Pharma Acquires CDMO

On July 27, 2020, LGM Pharma announced its acquisition of the formulation development and drug product contract manufacturing business of Nexgen Pharma, Inc. As a result, you will notice our new logo and visuals throughout the website. We’re working on updates to reflect the exciting, expanded CDMO capabilities and services we now can offer you.

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