FDA Approves ANI’s Abbreviated New Drug Application for Generic Tranxene

Clorazepate dipotassium tablets are for the management of anxiety disorders or for the short-term relief of symptoms.

The FDA has approved an abbreviated new drug application for clorazepate dipotassium tablets from ANI Pharmaceuticals for the management of anxiety disorders.1

“We continue to strengthen our base business with new product launches. The imminent launch and commercialization of clorazepate dipotassium tablets is another example of our ongoing commitment to ensuring that patients in need have access to important therapeutics,” Nikhil Lalwani, president and CEO of ANI, said in a statement.1

Clorazepate dipotassium tablets are the generic version of Tranxene (Recordati Rare Diseases Inc), which has an annual US market for clorazepate dipotassium of approximately $25.8 million, according to a statement from the company.1

The indications for Tranxene are for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety, as an adjunctive therapy in the management of partial seizures, and for the symptomatic relief of acute alcohol withdrawal.2

Tranxene is not indicated for use in individuals younger than aged 9 years. It contains clorazepate, which is a schedule IV-controlled substance.2

The most common adverse event (AEs) was drowsiness. Other AEs include ataxia, blurred vision, depression, diplopia, dry mouth, fatigue, gastrointestinal complaints, genitourinary complaints, headaches, insomnia, irritability, mental confusion, nervousness, . and slurred speech, transient skin rashes, and tremors.2

During 2019, approximately 9.5%, 3.4%, and 2.7% of adults experienced mild, moderate, or severe symptoms of anxiety in the past 2 weeks, respectively.

Approximately 84.4% experienced minimal or no symptoms, according to the CDC.3

Additionally, the number of adults who experienced anxiety symptoms was highest among those who were aged 18 to 29 years and decreased with age, with women more likely to experience anxiety than men.3

Further, non-Hispanic Asian adults were the least likely to experience anxiety compared with those who are Hispanic, non-Hispanic black, and non-Hispanic white adults.3

Generalized anxiety disorder is characterized by excessive worrying accompanied by difficulty concentrating, fatigue, irritability, muscle tension, restlessness, fatigue, or trouble sleeping, according to the CDC.3

Reference

1. ANI Pharmaceuticals announces FDA approval and imminent launch of clorazepate dipotassium tablets USP. Business Wire. News release. June 22, 2022. Accessed June 23, 2022. https://www.businesswire.com/news/home/20220622005246/en

2. United States Food and Drug Administration. Tranxene T-TAB Tablets (clorazepate dipotassium tablets, USP). Updated February 2021. Accessed June 23, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017105s084lbl.pdf

3. Symptoms of generalized anxiety disorder among adults: United States, 2019. CC. Updated September 23, 2020. Accessed June 23, 2022. https://www.cdc.gov/nchs/products/databriefs/db378.htm