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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-94/
- Published: 2019-06-02T12:00:00.000Z
- Updated: 2026-09-15T01:30:07.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5134624

**DEVICES**

**Entrotech Life** has received FDA 510(k) clearance for its ChloraDerm, an edge-to-edge transparent film dressing to provide a chlorhexidine matrix for wound and catheter site protection for up to seven days. “Compared to common non-antimicrobial dressings ChloraDerm demonstrates substantially greater effectiveness against multi-drug-resistant organisms at one, three and seven days, without adding increased cost or complexity,” the company says.

FDA has cleared a **PuraCath Medical** 510(k) for the FireFly Peritoneal Dialysis Connector Disinfecting System, intended for use by peritoneal dialysis (PD) patients as a method of controlling air and touch contamination while performing solution exchanges. The clearance was supported by in vitro testing that the company says demonstrated the device’s effectiveness in “achieving a 4-log reduction for several microorganisms which are known to cause peritonitis in PD patients.” The device reduces microbial growth through the use of a UV light-based PD disinfection system, it says.

FDA has cleared a **Velano Vascular** 510(k) for a modified version of its Velano needle-free blood draw device. The device clearance, according to the company, covers two modifications designed to enhance the product’s usability for inpatient blood draws — the addition of a clamp for use with syringe draws, a frequent practice in pediatric patients, and a refinement to its Indication for Use. The revised indication removes a limitation in the earlier clearance that specified when the device could be used with in-dwelling peripheral IV catheters.

**HUMAN DRUGS**

**Avanir Pharmaceuticals, Inc.** has received FDA approval for Onzetra Xsail(sumatriptan nasal powder), formerly known as AVP-825, for the acute treatment of migraine with or without aura in adults. It is an intranasal medication delivery system consisting of a 22mg dose of sumatriptan powder that is delivered via the Xsail Breath Powered Delivery Device.

FDA has approved a **Bristol-Myers Squibb** NDA for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for treating patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma. The indication was approved under the agency’s accelerated approval program based on progression-free survival. FDA also expanded the use of Opdivo as a single-agent to include previously untreated BRAF mutation-positive advanced melanoma patients. The drug was approved 11/2015 for use in previously untreated patients with BRAF V600 wild-type unresectable or metastatic melanoma.

**Eisai** has received approval from FDA for Halaven (eribulin mesylate) for treating unresectable or metastatic liposarcoma in patients who received prior chemotherapy containing an anthracycline drug. An agency news release says the drug’s safety and efficacy were evaluated in 143 clinical trial participants with advanced liposarcoma that was unresectable or had spread to nearby lymph nodes or other parts of the body and who had been treated with chemotherapy.

FDA has approved a **Merck** NDA for Zepatier (elbasvir and grazoprevir) with or without ribavirin for treating chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients.

**Takeda Pharmaceuticals** has received FDA approval of an NDA for Dexilant SoluTab (dexlansoprazole) delayed-release orally disintegrating tablets, a new formulation of the drug that can be taken by allowing the tablet to melt in a patient’s mouth. Dexilant SoluTab is a proton pump inhibitor indicated for treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease and the maintenance of healed erosive esophagitis and relief of heartburn in adults 18 years and older.

**VETERINARY**

FDA has approved **Lloyd, Inc.’s** Thyro Tabs Canine, the first animal drug to treat canine hypothyroidism.