Posted from: Friday, August 09, 2019 - 03:08 PM - Present

Ezallor Sprinkle Approved to Treat Elevated Lipid Disorders

July 15, 2019 – The U.S. FDA has approved Ezallor Sprinkle™ (rosuvastatin) capsules, a new dosage form of rosuvastatin manufactured by Sun Pharma. The product is indicated for use as an adjunct to diet to treat adult patients who have hypertriglyceridemia or who have primary dysbetalipoproteinemia (Type III hyperlipoproteinemia). It is also indicated to treat adult patients who have homozygous familial hypercholesterolemia (HoFH) by reducing LDL-C, total-C, and ApoB.

Ezallor Sprinkle was developed specifically for adult patients who have difficulty swallowing. Each capsule contains extended-release pellets that can be sprinkled over soft food, such as applesauce, or administered via nasogastric tube. The capsules can also be swallowed whole. Recommended dosing is 20mg per day for patients who have HoFH, and ranges from 5mg to 40mg once daily for other indications. The 40mg dose should only be used in patients who do not reach their LDL-C goal with a 20mg dose.

Rosuvastatin, the active ingredient in Ezallor Sprinkle, first received FDA approval in 2003. It is sold in another dosage form under the brand name Crestor®, from AstraZeneca, for which generics are currently available.

Last Updated Friday, October 11, 2019 - 08:31 AM.