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# Arbor Nymalize Suit Looks at FDA Product Withdrawal Reasons
- URL: https://www.fdaweb.com/arbor-nymalize-suit-looks-at-fda-product-withdrawal-reasons/
- Published: 2021-03-25T12:00:00.000Z
- Updated: 2026-09-14T16:52:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148975

A suit filed by Arbor Pharmaceuticals in a Georgia federal court challenging an FDA determination concerning the withdrawal of its original Nymalize (nimodipine) “raises interesting questions of statutory interpretation and the scope of FDA’s powers,” according to attorney **Sarah Cork** (Proskauer Rose). Writing in an online [post](https://www.natlawreview.com/article/generic-competition-withdrawn-drug-products?ref=fdaweb.com), Cork says the basis for a product’s withdrawal can affect whether a competitor can commercialize a generic version of the product. Thus, a generic cannot be approved if FDA determines that a product was withdrawn for reasons of safety and effectiveness.

Cork writes that Nymalize was approved in 5/2013 for improving neurological outcomes in certain aneurysm patients. At the time it could be administered in dose cups or through a nasogastric tube. The company later reformulated the drug to “mitigate some of the challenges and adverse effects” and submitted a sNDA on the “significantly modified” product. According to the post, the reformulated Nymalize contained the same dose of nimodipine as the original, but more concentrated and in a prefilled syringe.

In response to competitors’ petitions, FDA found that the original Nymalize had not been withdrawn for safety and effectiveness reasons. According to Cook, the agency reasoned that although discontinuation was one appropriate way to reduce the risk of confusion between the two formulations, it was not necessary to discontinue marketing because other mitigation strategies could be used to reduce the risk of confusion.

Cork says the company argues the agency determination violated the Administrative Procedures Act because: 

- there is no requirement that withdrawal be “necessary” to remedy a safety risk;
- Arbor’s decision to withdraw the original Nymalize was an “objectively reasonable” way to address the serious safety risks that FDA had said were likely to result if the product were still marketed;
- FDA rejected Arbor’s first risk mitigation proposal and it “beggars belief” to think that the company’s second proposal was accepted due to the “modest” other measures proposed alongside the withdrawal; and
- Similarly-situated products with risks of serious medication errors arising from the presence of multiple concentrations on the market have been deemed withdrawn for safety and effectiveness reasons.