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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-52/
- Published: 2022-05-22T12:00:00.000Z
- Updated: 2026-09-14T17:45:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134702

**DEVICES**

**BioArchitects** has gained FDA clearance to introduce its titanium patient specific cranial/craniofacial implants. The company says the plates are printed on Arcam AB‘s additive manufacturing 3D printers that use electron beam melting technology designed using CAD based on patient CT or MRI scans.

FDA has cleared a **Focal Healthcare** 510(k) for its targeted prostate biopsy device, Fusion Bx. The device is intended to assist clinicians in taking targeted biopsies directly from suspicious cancer regions within the prostate using MRI-ultrasound “fusion” technology, according to the company. “MRI has the ability to see tumors in the prostate that ultrasound alone cannot,” it says. “Thus, by fusing previously-acquired MR images to live ultrasound, clinicians can target suspicious tumors when taking biopsy samples. Fusion biopsy has been shown to detect high-grade cancer in 30% more men compared to traditional systematic biopsy.” The device also provides 2D and 3D image visualization, and incudes review, manipulation, and analysis tools.

**LivaNova** has received FDA approval of a PMA for its stented aortic bioprosthesis Crown PRT for treating aortic valve disease. The device features a “surgeon-friendly design, optimizing hemodynamics and the patented Phospholipid Reduction Treatment (PRT), which was designed to enhance valve durability,” the company says. The valve also allows, it says, for easy implantation with visible markers and improved radiographic visualization through dedicated X-ray markers. LivaNova’s Perceval valve, a sutureless biological device for use in aortic valve replacement procedures, was approved last month.

FDA has approved **Medtronic**’s Amplia MRI Quad CRT-D SureScan and Compia MRI Quad CRT-D SureScan defibrillators for patients requiring magnetic resonance imaging (MRI). The approvals cover MRI scans on any part of the body without positioning restrictions, the company says. Until now, CRT-Ds have been contraindicated by the FDA to undergo MRI scans because of the potential interaction between the MRI and the device, resulting in risk to patients, Medtronic says.

**HUMAN DRUGS**

FDA has approved an **Avanir Pharmaceuticals** NDA for Onzetra Xsail (sumatriptan nasal powder), formerly known as AVP-825, for the acute treatment of migraine with or without aura in adults. The intranasal medication delivery system comprises a low-dose (22mg) of sumatriptan powder that is delivered utilizing the Xsail Breath Powered Delivery Device, according to the company.

**Bracco Diagnostics** has received FDA approval of an NDA for E-Z-HD, a barium-based contrast agent for use in double-contrast radiographic examinations of the esophagus, stomach, and duodenum to visualize the gastrointestinal tract in patients 12 years and older. This is the first regulatory approval of a barium-based contrast agent in the U.S., according to the company.

FDA has approved an expanded indication for **Bristol-Myers Squibb**’s Daklinza (daclatasvir, 60 mg) — combination use with sofosbuvir (with or without ribavirin) in hepatitis C virus genotypes 1 and 3\. The expanded label includes data in three additional challenging-to-treat patient populations: chronic hepatitis C virus (HCV) patients with HIV-1 coinfection, advanced cirrhosis, or post-liver transplant recurrence of HCV. The Daklinza plus sofosbuvir regimen is already available for treating chronic HCV genotype 3, and is currently the only 12-week, once-daily all-oral treatment option for these patients.

**Dr. Reddy’s Laboratories** has received FDA approval of an NDA for Zembrace SymTouch (sumatriptan succinate) injection, a drug-device combination product (autoinjector) intended for treating acute migraine episodes, with or without aura, in adults who are inadequately managed with existing treatment regimens. The product is available as a prefilled, ready-to-use, single-dose disposable autoinjector containing 3 mg of sumatriptan, a selective 5-HT1B/ID receptor agonist. It is intended to be given subcutaneously.

**Promius Pharma**, a **Dr. Reddy**’s subsidiary, has received approval for Sernivo (betamethasone dipropionate) Spray, 0.05% from FDA. According to the company, it is a prescription topical steroid, indicated for treating mild to moderate plaque psoriasis in patients 18 years of age or older.

FDA has approved **Teligent, Inc.’**s ANDA for lidocaine ointment USP 5%, indicated for production of local or regional anesthesia.