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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-70/
- Published: 2017-12-10T12:00:00.000Z
- Updated: 2026-09-14T23:06:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140259

**DEVICES**

FDA has approved **Foundation Medicine**’s FoundationOne CDx (F1CDx), the first breakthrough-designated, next generation sequencing-based *in vitro* diagnostic test that can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type. An agency [news release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587273.htm?ref=fdaweb.com) says that compared to other companion diagnostics previously approved by FDA, the F1CDx is a more extensive test that provides information on a number of different genetic mutations that may help in the clinical management of cancer patients. Also, based on individual test results, the new test reportedly can identify which patients with any of five tumor types may benefit from 15 different FDA-approved targeted treatment options.

FDA has approved an **Advanced Bionics** PMA supplement to add an acoustic earhook for its Naída CI Q90 sound processor that transforms the device into a cochlear implant and hearing aid combination. The addition is designed to provide cochlear implant recipients with natural low-frequency hearing, according to the company. “The combination of electrical stimulation and low-frequency amplification is designed to provide sound quality enhancement as well as speech perception benefit for those with severe-to-profound hearing loss who no longer benefit from hearing aids alone,” it says.

**DRUGS**

FDA has approved **Mylan**’s Ogivri (trastuzumab-dkst), the first biosimilar to Genentech’s Herceptin, indicated for treating patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors over-express the HER2 gene. Ogivri is the first biosimilar approved in the U.S. for breast or stomach cancer.

FDA has approved a **ViiV Healthcare** NDA for Juluca, the first complete treatment regimen containing two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1). Current HIV combination products include three or more drugs included in standard HIV treatment. Approval is based on data from two clinical trials involving 1,024 patients whose virus was suppressed on their current anti-HIV drugs. Patients were randomly assigned to continue their current anti-HIV drugs or switch to Juluca. Data showed that Juluca was effective in maintaining virus suppression levels and results were comparable to those who continued their current therapy, the agency says.