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Clonazepam was approved in the United States as a generic drug in 1997 and is now manufactured and marketed by several companies. Clonazepam is available as tablets and orally disintegrating tablets (wafers) an oral solution (drops), and as a solution for injection or intravenous infusion. [139]
The first ODT form of a drug to get approval from the U.S. Food and Drug Administration (FDA) was a Zydis ODT formation of Claritin in December 1996. [19] It was followed by a Zydis ODT formulation of Klonopin in December 1997, [20] and a Zydis ODT formulation of Maxalt (rizatriptan) in June 1998. [21]
The anxiety-reducing drug, Clonazepam, has been recalled after a potentially "life-threatening" label mix-up, the FDA said in the recall.
Clonazepam: Rivatril, Rivotril, Klonopin, Iktorivil, Paxam: 1975 0.5, 1, 2 0.5-1: ... Drug Name Common Trade Names Year Approved Typical Dosages of Oral Tablets
Some packages of clonazepam were labeled with the incorrect dosage strength and National Drug Code (NDC), which is the FDA's identifier for drugs, according to Endo, Inc., the drug's manufacturer.
In the Food and Drug Administration’s (FDA) recall alert posted on Nov. 19, the pharmaceutical company is investigating and expanding its previously announced voluntary recall of Clonazepam.
The usual method of achieving approval for a drug is to show it is effective when compared against placebo, or that it is more effective than an existing drug. In monotherapy (where only one drug is taken) it is considered unethical by most to conduct a trial with placebo on a new drug of uncertain efficacy.
Endo, Inc., the manufacturer of clonazepam, expanded the recall, first announced in July, to 16 lots of the medication, according to a recall notice shared by the FDA on Nov. 19.
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