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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-20/
- Published: 2021-10-03T12:00:00.000Z
- Updated: 2026-09-14T17:17:22.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142153

**DEVICES**

FDA has approved **Grifols**’ Procleix Zika Virus assay for detecting the virus in individual or pooled plasma specimens from human donors, including volunteer donors of whole blood and blood components for transfusion. The assay is also approved for testing plasma or serum specimens to screen other living (heart-beating) or cadaveric (non-heart beating) organ donors and cell- and tissue-based products. The assay has been in use since 6/2016 under an IND. It is performed on the Procleix Panther system automated platform using nucleic acid technology, according to the company.

FDA has granted de novo marketing for **Natural Cycles** Nordic’s Natural Cycles mobile medical application that can be used as a method of contraception to prevent pregnancy. The app contains an algorithm that calculates the days of the month a woman is likely to be fertile based on daily body temperature readings and menstrual cycle information, a contraceptive method called fertility awareness. Designed for mobile devices, it is intended for use in pre-menopausal women aged 18 and older.

**DRUGS**

FDA has approved **Eisai** and **Merck**’s kinase inhibitor Lenvima (lenvatinib) for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). Approval was based on results from REFLECT (Study 304), where Lenvima demonstrated a proven treatment effect on overall survival, as well as statistically significant superiority and clinically meaningful improvements in progression-free survival and objective response rate when compared with sorafenib in patients with previously untreated unresectable HCC, they say.

FDA has approved **Sun Pharmaceutical Industries**’ Cequa (cyclosporine ophthalmic solution) 0.09%, indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye). The drops provide the highest FDA-approved concentration of cyclosporine A and is the first cyclosporine A product that incorporates a nanomicellar technology, according to the company. The formulation “allows the CsA molecule to overcome solubility challenges, penetrate the eye’s aqueous layer and prevents the release of the active lipophilic molecule prior to penetration,” it says.