Drugs

Recall Unapproved Phenobarb Products: Sun

Sun Pharma is asking FDA to ask the manufacturers of unapproved phenobarbitol products to recall drugs that contain excipients that are known to be harmful to neonates. It also is asking the agency to inform the public and healthcare providers about the “serious risks associated with the use of unapproved phenobarbitol products in neonates and other infants.”

The company’s petition notes that its Sezaby (phenobarbitol sodium) was approved by FDA in 11/2022 as a sterile injectable indicated to treat neonatal seizures in term and preterm infants. The company says there is no other FDA-approved use for phenobarbitol sodium.

“Sezaby is a lyophilized, preservative-free powder for reconstitution and, as such, does not expose neonates to any excipients at all,” the petition says. It lists five products that it says are marketed in the U.S., including for infants, without FDA approval and lists the excipients in each of them. “Each of those unapproved new drugs contains at least two of the three excipients that FDA has identified as presenting ‘known toxicity’ to nenonates,” Sun says.

The petition says the manufacturers and marketers of the unapproved drugs objectively intend for their products to be used to treat seizures in term and preterm neonates.

“With the approval of Sezaby,” Sun concludes, “there is no longer any reason that healthcare providers and patients should continue to use unapproved phenobarbitol sodium products.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome