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In 2013 Breckenridge launched several Abbreviated New Drug Applications (ANDAs), including: carbinoxamine maleate tablets and liquid, cilostazol tablets (Pletal), lansoprazole capsules (Prevacid), pioglitazone capsules (Actos), propranolol LA capsules (Inderal LA) and rizatriptan IR and ODT tablets (Maxalt & Maxalt MLT).
The first products targeted then were unapproved prescription products containing the antihistamine carbinoxamine, which had been linked to 21 deaths in children under age 2.
The first products targeted were unapproved prescription products containing the antihistamine carbinoxamine, which had been linked to 21 deaths in children under age 2.
Two of the infants (patients 1 and 2) had been administered prescription medications containing carbinoxamine (an antihistamine), although neither had detectable postmortem blood levels of carbinoxamine.
The FDA said it was targeting carbinoxamine because of safety concerns, including 21 deaths since 1983 in children under age 2 that may be related to the ingredient.
Pamlab, LLC, has launched Palgic[R], a new prescription antihistamine featuring carbinoxamine maleate.
Featured products on the Boca Pharmacal web site include antipyrine and benzocaine otic solution; levetiracetam 250-mg, 500-mg and 750-mg tablets; methscopolamine bromide 2-mg tablets USP; methscopolamine bromide 5-mg tablets USP; and carbinoxamine maleate 4-mg liquid and tablets.
In June 2006, the FDA said it was strengthening its efforts to address unapproved drug products and that it was acting to stop the marketing of unapproved products containing carbinoxamine because of safety concerns in children under age 2.
In June 2006, the FDA announced that it was strengthening its efforts to address unapproved drug products and that it was acting to stop the marketing of unapproved products containing carbinoxamine because of safety concerns in children under age 2.
Carbinoxamine is used in cough and cold treatments, mostly for children, that have been associated with 21 reported deaths since 1983.