OINDPnews


Aptar Pharma banner

Regulatory

FDA approves new device for use with Tyvaso inhalation solution

The FDA has approved an updated nebulizer for use with United Therapeutics' Tyvaso treprostinil inhalation solution for the treatment of pulmonary arterial hypertension, the company said. The new TD-300/A device will be launched next year. According to United Therapeutics, the TD-300/A nebulizer "has a cleaner, more ergonomic design that includes single button … [Read more...] about FDA approves new device for use with Tyvaso inhalation solution

Evoke announces positive results for Gimoti metoclopramide nasal spray PK study

Evoke Pharma says that a comparative exposure PK study has shown that 2 out of 3 doses of its Gimoti metoclopramide nasal spray demonstrated bioequivalence to oral metoclopramide and, based on those results, the company plans to submit a 505(b)(2) NDA for Gimoti early in 2018. Evoke is developing Gimoti for the treatment of diabetic gastroparesis. In December … [Read more...] about Evoke announces positive results for Gimoti metoclopramide nasal spray PK study

Flutiform k-haler for the treatment of asthma gets European approval

According to Mundipharma, the Flutiform fluticasone propionate/formoterol fumarate k-haler breath-activated MDI has received marketing approval through the European decentralized procedure for the treatment of asthma in patients 12 and older. The company had submitted the MAA in March 2016. Flutiform k-haler delivers the same dosages as the existing Flutiform MDI, … [Read more...] about Flutiform k-haler for the treatment of asthma gets European approval

Aradigm’s NDA for Linhaliq gets priority review status from FDA

According to Aradigm Corporation, the FDA has accepted its NDA for Linhaliq dual release inhaled ciprofloxacin for the treatment of chronic P. aeruginosa infections in non-cystic fibrosis bronchiectasis (NCFBE) patients for priority review. The agency set a PDUFA date of January 26, 2018. Aradigm announced its submission of the NDA in July 2017. Linhaliq … [Read more...] about Aradigm’s NDA for Linhaliq gets priority review status from FDA

Trelegy Ellipta approved by the FDA

GlaxoSmithKline announced that its NDA for Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol for the treatment of COPD has been approved by the FDA. GSK said that Trelegy Ellipta should be available to patients in the US "shortly." The FDA approval comes days after the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion … [Read more...] about Trelegy Ellipta approved by the FDA

Optinose’s Xhance fluticasone propionate nasal spray gets FDA approval

The FDA has approved Optinose's Xhance fluticasone propionate nasal spray (formerly OPN-375) for the treatment of nasal polyps, the company said. The product, which is based on the company's exhalation delivery technology, should be available in the US by mid-2018. In January 2017, OptiNose announced that the FDA had accepted its NDA for OPN-375. The company had … [Read more...] about Optinose’s Xhance fluticasone propionate nasal spray gets FDA approval

Mundipharma’s Nyxoid naloxone nasal spray gets positive opinion from CHMP

The EMA Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Mundipharma's MAA for Nyxoid naloxone nasal spray for the reversal of opioid overdose. Currently, no intranasal naloxone formulations are approved for use across the entire EU. Indivior's Nalscue nasal spray was approved in France in July 2017. Adapt Pharma submitted an MAA … [Read more...] about Mundipharma’s Nyxoid naloxone nasal spray gets positive opinion from CHMP

CHMP issues positive opinion regarding GSK’s Trelegy Ellipta triple combination DPI

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding GSK's MAA for its triple combination fluticasone furoate/umeclidinium/vilanterol DPI for the treatment of COPD in patients whose symptoms are not adequately controlled by an ICS/LABA combination. GSK plans to market the product in Europe … [Read more...] about CHMP issues positive opinion regarding GSK’s Trelegy Ellipta triple combination DPI