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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-18/
- Published: 2021-09-19T12:00:00.000Z
- Updated: 2026-09-14T17:15:10.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137668

**DEVICES**

FDA has granted a **Roche** *de novo* request to allow the marketing of its Anti-Müllerian (AMH) assay, which the company calls the first approved fully automated AMH test available in the U.S. to help women who are planning to become pregnant or struggling with infertility. The blood test is intended to measure serum AMH to assess ovarian reserve.

FDA has expanded the approved use of **Dexcom**’s G5 mobile continuous glucose monitoring system to allow for replacement of fingerstick blood glucose testing for diabetes treatment decisions in people age 2 and older who have diabetes, an agency media [release](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm534056.htm?ref=fdaweb.com) says. Dexcom’s is the first FDA-approved continuous glucose monitoring system that can be used to make diabetes treatment decisions without confirmation through a traditional fingerstick test.

**DRUGS**

FDA has given accelerated approval to **Clovis Oncology**’s Rubraca (rucaparib) to treat women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a specific gene mutation, deleterious BRCA, as identified by an FDA-approved companion diagnostic test. An agency [news release](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm533873.htm?ref=fdaweb.com) says the FoundationFocus CDxBRCA companion diagnostic is manufactured by Foundation Medicine. Some 15-20% of ovarian cancer patients have the BRCA mutation, FDA says.

FDA has approved **Biogen**’s Spinraza (nusinersen) for treating children and adults with spinal muscular atrophy. Spinraza, the first drug indicated for this condition, is an injection administered into the fluid surrounding the spinal cord, FDA said in an [announcement](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm534611.htm?ref=fdaweb.com). The agency said it worked closely with Biogen and Ionis Pharmaceuticals, which developed the drug, during development to help design and implement the analysis upon which the approval was based.