Envarsus XR
Generic name: tacrolimus
Treatment for: Organ Transplant, Rejection Prophylaxis
Veloxis Announces Tentative Approval of Envarsus XR
Hørsholm, Denmark - 31 October 2014 -- Veloxis Pharmaceuticals A/S (OMX: VELO) announced today that the U.S. Food and Drug Administration has informed Veloxis of the tentative approval of Envarsus XR. FDA stated that the final approval of Envarsus XR will be delayed until expiration of the exclusivity period for Astellas' Astagraf XL®. Veloxis understands that this expiry is anticipated to occur July 19, 2016. FDA's approval notice stated that it is "subject to change on the basis of any new information that may come to FDA's attention."
Veloxis disagrees that exclusivity for Astagraf XL, which was not identified as a listed drug or relied upon to support approval of Envarsus XR, should require delay in the formal approval of Envarsus XR. Veloxis plans to immediately appeal this decision within FDA, and will pursue all options available to it.
The tentative approval notification received from FDA included agreement with manufacturing post-marketing commitments as previously proposed by Veloxis during NDA review as well as agreement on final labeling for the product. There were no other conditions attached to the NDA approval.
About Veloxis Pharmaceuticals
Based in Hørsholm, Denmark, with an office in New Jersey, Veloxis Pharmaceuticals A/S, or Veloxis, is a specialty pharmaceutical company. Veloxis' unique, patented delivery technology, MeltDose®, is designed to enhance the absorption and bioavailability of select orally administered drugs. Veloxis is listed on the NASDAQ OMX Copenhagen under the trading symbol OMX: VELO.
Source: Veloxis Pharmaceuticals A/S
Posted: October 2014
Related articles
- FDA Approves New Indication for Envarsus XR (tacrolimus extended-release tablets) - December 19, 2018
- FDA Approves Envarsus XR (tacrolimus) for Prevention of Organ Rejection in Kidney Transplant Patients - July 10, 2015
- FDA Accepts NDA for Envarsus for the Prevention of Organ Rejection in Kidney Transplant Patients - March 13, 2014
- Veloxis Pharmaceuticals Announces NDA Submission for Envarsus in Kidney Transplant Recipients - December 30, 2013
Envarsus XR (tacrolimus) FDA Approval History
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