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# Regulatory Review Determinations on 8 NDAs
- URL: https://www.fdaweb.com/regulatory-review-determinations-on-8-ndas/
- Published: 2023-11-29T12:00:00.000Z
- Updated: 2026-09-14T14:17:17.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155878

*Federal Register* notices: FDA has published eight notices about the regulatory review period determinations for the following drug products:

- KemPharm’s Azstarys (serdexmethylphenidate and dexmethylphenidate), indicated for treating attention deficit hyperactivity disorder in patients six years of age and older. The regulatory review period is 1,676 days, of which 1,244 days occurred during the testing phase and 432 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-11-29/pdf/2023-26246.pdf?ref=fdaweb.com).
- Apellis Pharmaceuticals’ Empaveli (pegcetacoplan), indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria. The regulatory review period is 2,501 days, of which 2,258 days occurred during the testing phase and 243 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-11-29/pdf/2023-26255.pdf?ref=fdaweb.com).
- Bayer’s Kerendia (finerenone), indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease associated with Type 2 diabetes. The regulatory review period is 2,950 days, of which 2,707 days occurred during the testing phase and 243 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-11-29/pdf/2023-26251.pdf?ref=fdaweb.com).
- Aurinia Pharmaceuticals’s Lupkynis (voclosporin), indicated in combination with a background immunosuppressive therapy regimen for treating adult patients with active lupus nephritis. The regulatory review period is 7,584 days, of which 7,338 days occurred during the testing phase and 246 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-11-29/pdf/2023-26247.pdf?ref=fdaweb.com).
- Trevena’s Olinvyk (oliceridine fumarate), indicated for managing acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The regulatory review period is 3,206 days, of which 2,112 days occurred during the testing phase and 1,094 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-11-29/pdf/2023-26253.pdf?ref=fdaweb.com).
- Takeda Pharmaceutical’s Orgovyx (relugolix), indicated for treating adult patients with advanced prostate cancer. The regulatory review period is 4,875 days, of which 4,632 days occurred during the testing phase and 243 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-11-29/pdf/2023-26258.pdf?ref=fdaweb.com).
- Progenics Pharmaceuticals’ Pylarify (piflufolastat F18), indicated for positron emission tomography of prostate-specific membrane antigen positive lesions in men with prostate cancer. The regulatory review period is 2,681 days, of which 2,441 days occurred during the testing phase and 240 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-11-29/pdf/2023-26261.pdf?ref=fdaweb.com).
- Array BioPharma and Seattle Genetics’ Tukysa (tucatinib), indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer. The regulatory review period is 4,653 days, of which 4,533 days occurred during the testing phase and 120 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-11-29/pdf/2023-26256.pdf?ref=fdaweb.com).