Product Approval Summaries

DEVICES

Additive Orthopedics has received FDA 510(k) clearance for its 3D printed titanium digital fusion implant for use in fusion procedures.

FDA has approved Advanced Accelerator Applications’ Netspot, the first kit for preparing gallium Ga 68 dotatate injection, a radioactive diagnostic agent for locating somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. NETs are rare benign or malignant tumors that develop in the hormone-producing cells of the body’s neuroendocrine system, according to an agency release. They have receptors for somatostatin, a hormone that regulates the endocrine system, and Ga 68 dotatate, a positron emitting somatostatin analog, works by binding to the receptors, it says.

FDA has cleared a First Ray 510(k) for the SpeedButton System for attaching soft tissue to bone. “Reattachment of ligaments and capsular tissue to bone using conventional suture anchors is problematic in the presence of decortication at the attachment site,” the company says. “Quality of the fixation may be compromised, and the suture anchor can potentially occupy and occlude a portion of the soft tissue footprint available for healing.” The company says the the SpeedButton solves these issues by using a transosseous fixation technique in the cortical bone opposite the soft tissue reattachment site.

Roche has received FDA approval of its cobas EGFR Mutation Test v2, a companion diagnostic for the cancer drug Tarceva (erlotinib) that is the first blood-based genetic test detect epidermal growth factor receptor (EGFR) gene mutations in non-small cell lung cancer patients, according to an agency release.

HUMAN DRUGS

Allergan has received approval from FDA to market Juvéderm Volbella XC for use in the lips for lip augmentation and for correction of perioral rhytids, commonly referred to as perioral lines, in adults over the age of 21.

FDA has approved a Boehringer Ingelheim and Eli Lilly NDA for Jentadueto XR (linagliptin and metformin hydrochloride extended-release) tablets for treating Type 2 diabetes in adults. Linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, works by increasing hormones that stimulate the pancreas to produce more insulin and the liver to produce less glucose, according to the companies. Metformin works by lowering glucose production by the liver and its absorption in the intestine. The companies say that Jentadueto XR should not be used in patients with Type 1 diabetes or for treating diabetic ketoacidosis, and has not been studied in people with a history of pancreatitis.

FDA has granted Intercept Pharmaceuticals accelerated approval for Ocaliva (obeticholic acid) for treating primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as a single therapy in adults unable to tolerate UDCA. The condition causes the small bile ducts in the liver to become inflamed, damaged and ultimately destroyed, which causes bile to remain in the liver and leads to cirrhosis.

Titan Pharmaceuticals and Braeburn Pharmaceuticals have received FDA approval of Probuphine, a first-of-its-kind buprenorphine implant for use by those dependent on opioids. The companies say the implant offers many advantages over other delivery methods, such as a pill form and as a film that dissolves under the tongue.

VETERINARY

FDA approved Aratana Therapeutics’ Entyce (capromorelin oral solution), a new animal drug indicated for appetite stimulation in dogs. A CVM update called the drug a selective ghrelin receptor agonist that binds to receptors that stimulate appetite and a laboratory study had shown that Entyce increased appetite in normal healthy dogs.