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Loreev XR FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 15, 2021.

FDA Approved: Yes (First approved August 27, 2021)
Brand name: Loreev XR
Generic name: lorazepam
Dosage form: Extended-Release Capsules
Company: Almatica Pharma LLC
Treatment for: Anxiety

Loreev XR (lorazepam) a once daily benzodiazepine formulation indicated for the treatment of anxiety disorders in adults.

  • Loreev XR is for use in patients who have been receiving stable, evenly divided, three times daily dosing with immediate release lorazepam tablets. The recommended dosage of Loreev XR is equal to the total daily dose of lorazepam tablets.
  • Loreev XR is supplied as extended-release capsules in 1 mg, 2 mg, and 3 mg strengths.
  • Loreev XR capsules are administered orally, once daily in the morning.
  • Loreev XR may cause serious adverse reactions including CNS depression, worsening of pre-existing depression or psychosis, and allergic reactions. The Loreev XR product label carries a boxed warning for risks with concomitant use of opioids, misuse and addiction, and withdrawal reactions.
  • Common side effects include sedation, dizziness, weakness, and unsteadiness.

 

 

Further information

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