Content about Budesonide

February 4, 2014

Salix Pharmaceuticals announced that the Food and Drug Administration has accepted for filing a new drug application for Budesonide 2 mg Rectal Foam for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.

RALEIGH, N.C. — Salix Pharmaceuticals last week announced that the Food and Drug Administration has accepted for filing a new drug application for Budesonide 2 mg Rectal Foam for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.

The FDA has issued an action date of Sept. 15, 2014 under the Prescription Drug User Fee Act. 

May 28, 2013

A federal court has blocked Actavis from distributing its generic version of a drug for treating asthma, the company said.

PARSIPPANY, N.J. — A federal court has blocked Actavis from distributing its generic version of a drug for treating asthma, the company said.

Actavis said the U.S. Court of Appeals for the Federal Circuit had issued an injunction against Actavis' distribution of budesonide inhalation suspension at the request of AstraZeneca, which sells the drug under the trade name Pulmicort Respules.

January 16, 2013

The Food and Drug Administration has approved an ulcerative colitis drug made by Santarus, the drug maker said.

SAN DIEGO — The Food and Drug Administration has approved an ulcerative colitis drug made by Santarus, the drug maker said.

Santarus announced the approval of Uceris (budesonide) extended-release tablets for mild to active UC. The company plans to launch the drug in March.

August 1, 2012

The Food and Drug Administration has approved a generic drug designed to treat asthma in children.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic drug designed to treat asthma in children.

Watson Pharmaceuticals announced Wednesday the approval of budesonide inhalation suspension in the 0.25-mg/2-mL and 0.5-mg/2-mL strengths. The drug is used to control and prevent asthma symptoms in children ages 12 months to 8 years.

The drug is a generic version of AstraZeneca's Pulmicort Respules, which had sales of $1.1 billion during the 12-month period ended in May.

November 14, 2010

Most patients with mild persistent asthma overuse a drug combination despite an apparent lack of...

PHOENIX — Most patients with mild persistent asthma overuse a drug combination despite an apparent lack of added medical benefit, according to a new study by pharmacy benefit manager Medco.

May 17, 2010

Teva Pharmaceutical Industries and AstraZeneca have reached a settlement that will allow Teva to market...