CLL/SLL |FL |MCL |MZL
The FDA grants final approval of abbreviated new drug application for generic bendamustine hydrochloride
On the 6th January 2017, the U.S. Food and Drug Administration (FDA) granted final approval of an Abbreviated New Drug Application (ANDA) submitted by Breckenridge Pharmaceutical Inc. and Natco Pharma Ltd. for their generic version of bendamustine hydrochloride powder for IV.1
Their drug product is a generic version of Cephalon Inc.’s TREANDA®, marketed in the US, and indicated to treat CLL and indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
Breckenridge and Natco intend to launch their ANDA on 1st November 2019 (potentially earlier depending on circumstances), and will be available in 25mg/vial and 100mg/vial strengths.
A generic drug is comparable to innovator drugs in dosage form, strength, route of administration, quality, performance characteristics, and intended use. Generic drugs can be launched very quickly after the patent of the branded equivalent expires, and are sold at a significantly discounted price versus their branded predecessor.2
An ANDA3 submission to the FDA’s Center for Drug Evaluation and Research, Office of Generic Drugs, contains data for review for ultimate approval of a generic drug product. Once approved, the generic drug can be manufactured and brought to market as a safe, effective, and low cost alternative.
- PR Newswire. Breckenridge Pharmaceutical, Inc. Announces Final ANDA Approval for Bendamustine HCl Powder for IV (Treanda®). 2017 Jan 6. http://www.prnewswire.com/news-releases/breckenridge-pharmaceutical-inc-announces-final-anda-approval-for-bendamustine-hcl-powder-for-iv-treanda-300387195.html. [Accessed 2017 Jan 20].
- Seget S. Pharmaceutical Pricing Strategies: Optimizing returns throughout R&D and marketing. http://www.amcp.org/WorkArea/DownloadAsset.aspx?id=13217. [Accessed 2017 Jan 20].
- Abbreviated New Drug Application (ANDA): Generics. 2016 Nov 16. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/. [Accessed 2017 Jan 20].