Insys Therapeutics says that it plans NDA submissions for both its naloxone and epinephrine nasal sprays in 2019. The company also noted the potential of regulatory submission for its inhaled dronabinol in the next few years. According to Insys, a PK study of the naloxone nasal spray "showed a distinctive profile for the . . . nasal spray product candidate in … [Read more...] about Insys says it plans NDA submissions for two nasal sprays in 2019
Regulatory
Pharmaxis relaunches Aridol in the US
Pharmaxis said that its distribution partner Methapharm Inc. has begun selling Pharmaxis' Aridol mannitol bronchial challenge test kit again in the United States. According to the company, its Sydney, Australia manufacturing facility received FDA approval to manufacture Aridol for the US market in August 2018. Aridol is also approved in Australia, South Korea, and … [Read more...] about Pharmaxis relaunches Aridol in the US
Zambon’s inhaled colistimethate sodium gets QIDP and fast track designations
Zambon has announced that its colistimethate sodium powder for nebulized delivery as a solution by the Philips i-neb nebulizer system, has received QIDP and fast track designations from the FDA for the prevention of exacerbations in non-cystic fibrosis bronchiectasis patients with P. aeruginosa lung infections. The company said that two Phase 3 studies of … [Read more...] about Zambon’s inhaled colistimethate sodium gets QIDP and fast track designations
Auris Medical’s intranasal betahistine gets orphan drug designation, expanded development
According to Auris Medical, the FDA has granted orphan drug designation to its intranasal betahistine for the treatment of obesity associated with Prader-Willi syndrome (PWS). The company also said that it has signed a letter of intent to in-license rights to US patents covering the use of betahistine for two other indications, depression and … [Read more...] about Auris Medical’s intranasal betahistine gets orphan drug designation, expanded development
Tiziana initiates Phase 1 trial of intranasal foralumab
Tiziana Life Sciences has announced that the FDA approved the company's IND for intranasal foralumab human anti-CD3 antibody, and a Phase 1 clinical trial has begun. Tiziana licensed foralumab from Novimmune in 2014 and is developing the nasal formulation for the treatment of neurodegenerative diseases such as multiple sclerosis. The dose escalating trial, … [Read more...] about Tiziana initiates Phase 1 trial of intranasal foralumab
FDA issues revised draft guidances for sumatriptan and zolmitriptan nasal sprays
Revised draft guidances for sumatriptan and zolmitriptan nasal sprays are included in the most recent batch of product-specific guidances for generic drug development issued by the FDA. The agency says that it "publishes these product-specific guidances to foster drug product development, and ANDA submission and approval, ultimately providing increased access to safe, … [Read more...] about FDA issues revised draft guidances for sumatriptan and zolmitriptan nasal sprays
FDA approves Lupin budesonide inhalation suspension
According to Lupin, the FDA has approved its ANDA 0.5 mg/2 mL single dose ampules of budesonide inhalation suspension, a generic version of AstraZeneca's Pulmicort Respules, for the treatment of asthma in children aged 12 months to 8 years. Other companies with approved ANDAs for budesonide inhalation suspension 0.5 mg/2 mL include Apotex (licensed to Nephron), … [Read more...] about FDA approves Lupin budesonide inhalation suspension
FDA approves Yupelri revefenacin inhalation solution for COPD
According to Theravance Biopharma and Mylan, the FDA has approved the NDA for Yupelri revefenacin inhalation solution for the treatment of COPD. The NDA was submitted in November 2017, and the FDA accepted the application for review in January 2018. The two companies announced in 2015 that they would partner to develop revefenacin, then known as TD-4208, as an … [Read more...] about FDA approves Yupelri revefenacin inhalation solution for COPD
Trelegy Ellipta gets expanded indication for COPD in Europe
According to GlaxoSmithKline and Innoviva, the European Commission has approved a label change for the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI, extending its use to patients with moderate to severe COPD who do not achieve adequate relief of symptoms with a dual bronchodilator. Trelegy Ellipta was approved in Europe in 2017 for COPD patients not … [Read more...] about Trelegy Ellipta gets expanded indication for COPD in Europe
Flutiform okayed for pediatric use in Europe
Mundipharma has announced that its license variation application to extend the use of the Flutiform fluticasone propionate/formoterol MDI to asthma patients aged 5 up to 12 years for whom an ICS/LABA combination is appropriate has received a positive opinion. Flutiform has been approved in Europe for the treatment of asthma in patients 12 and older since 2012. The … [Read more...] about Flutiform okayed for pediatric use in Europe