Novartis' Jadenu Sprinkle, or deferasirox, has been approved by the FDA as a new formulation to treat patients at least 2 years old with chronic iron overload due to blood transfusions, and in patients at least 10 years old with chronic iron overload in nontransfusion-dependent thalassemia syndromes. The new granule formulation allows the drug to be sprinkled on soft food and given orally to patients.
Aurobindo Pharma's generic amlodipine and olmesartan medoxomil tablets, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg, have been approved by the FDA as a treatment for patients with hypertension as the generic equivalent to the reference drug, Daiichi Sankyo's Azor. Aurobindo's Glipizide extended-release tablets, 2.5 mg, 5 mg and 10 mg, were also granted FDA approval for diabetes indication as a generic equivalent to Pfizer's Glucotrol XL.
The US Food Safety and Inspection Service expanded its recall of boneless veal products imported from the Netherlands over possible contamination with E. coli to cover more than 1,600 pounds of products. The recall now includes 13 varieties of chilled boxes of boneless veal, which were distributed to restaurants and grocery stores in Florida, Massachusetts, Michigan and California.
Australia's Therapeutic Goods Administration has proposed the use of overseas marketing approval of medical devices to support inclusion in the Australian Register of Therapeutic Goods or the sharing of such work with comparable overseas regulators to advance parallel submissions. Under the proposal, which is open for comments until June 30, the Australian regulator would only evaluate International Medical Device Regulators Forum members but would also use application-by-application assessment for work-sharing agreements.
A recall initiated by Royal Philips' Respironics business involving 20,690 units of its V60 noninvasive ventilator has been classified by the FDA as Class I. The recall was issued over concerns about the risk of serious adverse health consequences that could happen if the ventilation unexpectedly shut down because of a loose pin within the internal cable connecting the motor to the control board.
Canton, Mass.-based advanced wound care innovation and technologies developer Organogenesis has secured a financing facility worth $20 million from Eastward Capital Partners. The money will be used for the continued enhancement of the company's product portfolio.
Philips has agreed to pay an undisclosed amount for St. Paul, Minn.-based Respiratory Technologies, which manufactures the inCourage line of inflatable, pulsating airway-clearance vests for treating patients with chronic respiratory conditions. RespirTech, with revenue closing in on $50 million this year, will maintain its executive team, as well as its operations in the Twin Cities.
Finesse Medical, an Irish company that makes products for wound care, has been acquired by US-based Avery Dennison for undisclosed terms. Finesse Medical, which made approximately $16.8 million in revenue last year, is expected to complement Avery Dennison's Vancive Medical Technologies subsidiary.
Singapore-based QT Vascular has announced that it is in talks with interested third parties to seek out potential deals for its coronary products. The company said potential transactions will not involve or be in conflict with the Chocolate PTA nondrug-coated balloon, on which Medtronic has already agreed to pay $28 million for an option.
A Meddevicetracker report predicts the global sales of spinal cord stimulation systems will reach $2.4 billion by 2021 with a 6% compound annual growth rate. The largest market growth will continue to come from the dominant market, the US, because of the increasing demand for pain-management solutions from an expanding aging and obese population, more regulatory approvals of SCS products and an increasing interest in the use of the devices as an alternative treatment.