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# Melinta Raises Covid-Related Issue with Nexus ANDA
- URL: https://www.fdaweb.com/melinta-raises-covid-related-issue-with-nexus-anda/
- Published: 2021-10-19T12:00:00.000Z
- Updated: 2026-09-14T17:19:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150392

Melinta Therapeutics is asking FDA to take several actions on a Nexus Pharmaceuticals ANDA that relies on Melinta’s Minocin (minocycline) 100 mg/vial as the reference-listed drug. A Melinta 10/16 [petition](https://downloads.regulations.gov/FDA-2021-P-1123-0001/attachment%5F1.pdf?ref=fdaweb.com) says there are issues with the Nexus ANDA related to Melinta’s offices being closed in 2020 due to the Covid-19 pandemic. The petition asks that FDA: 

- refuse to approve and/or tentatively approve the Nexus ANDA before expiration of two Minocin patents that are valid through 5/12/31 unless and until Nexus resends a notice of Paragaph 4 certification and provides credible and timely proof of receipt;
- deem all Paragraph 4 patent certifications included to date in the Nexus ANDA to have been converted to Paragraph 3 certifications.

The petition contains requested alternatives if the agency doesn’t grant the first two items.

The petition says Melinta first obtained on 3/31/21 a FedEx Priority Overnight letter from Nexus dated 12/7/20 “purporting to notify Melinta’s general counsel of a Paragraph 4 certification in the ANDA for a generic form of Minocin.”

Melinta says Nexus did not meet regulatory requirements for such a notice because Melinta’s offices were closed since 3/16/20, with employees working from home. Melinta says it made arrangements for handling all mail delivered to the office and the Nexus letter did not go through the established process.

“Melinta did not receive, and there is no credible or compliant evidence that Melinta ‘received’ under the Federal Food, Drug, and Cosmetic Act and FDA regulations, the Nexus letter on 12/8/20, as Nexus appears to claim,” the petition says