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# New Requests in Radius Petition Supplement
- URL: https://www.fdaweb.com/new-requests-in-radius-petition-supplement/
- Published: 2022-11-02T12:00:00.000Z
- Updated: 2026-09-14T18:04:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153113

Radius Health has submitted a supplement to its 4/22 petition regarding its Tymlos (abaloparatide) injection. The [supplement](https://downloads.regulations.gov/FDA-2021-P-0413-0004/attachment%5F1.pdf?ref=fdaweb.com) asks that FDA take these actions, in addition to those requested in the original petition:

- refuse to grant an A-therapeutic equivalence rating to any ANDA or 505(b)(2) NDA referencing Tymlos for subcutaneous use unless the application demonstrates the same incidence of anti-abaloparatide antibodies, neutralizing antibodies, and cross-reactive antibodies as Tymlos using a clinically validated immunoassay;
- record the agency’s assessment of the scientific and legal issues raised in the petition and supplement when it considers any ANDA or 505(b)(2) NDA that references Tymlos; and
- consider the issues raised by the petition and supplement in developing guidance and reviewing applications for follow-on versions of parathyroid hormone analogs, and in the agency’s final guidance on the evaluation of therapeutic equivalence.

The original petition asked FDA to:

- refuse to grant an A-therapeutic rating to any ANDA or 505(b)(2) NDA that references Tymlos for subcutaneous use unless it demonstrates a stable pH value of 5.1 to 5.2;
- refuse to grant an A-therapeutic rating to any ANDA or 505(b)(2) NDA that references Tymlos unless it contains the degradant Beta-Asp10-abaloparatide in an amount less than 0.5% of its drug substance; and
- refuse to file any ANDA for recombinant abaloparatide.