Regulatory

Janssen Pharmaceutical announced that the company has submitted a type II variation application for Spravato esketamine nasal spray to the EMA seeking to expand the use of Spravato for the treatment of major depressive disorder (MDD) in patients who have active suicidal ideation with intent. Spravato was approved in Europe in December 2019 for the treatment of … [Read more...] about Janssen submits type II variation application for Spravato

The FDA has approved Neurelis's Valtoco diazepam nasal spray for the treatment of seizure clusters or acute repetitive seizures in epilepsy patients aged 6 years and older. Neurelis submitted the 505(b)(2) NDA for Valtoco in September 2018. Valtoco, which was formerly known as NRL-1, was granted orphan drug designation in December 2015 and Fast Track designation in … [Read more...] about FDA approves Valtoco diazepam nasal spray for the treatment of seizure clusters

Seelos Therapeutics said that it has scheduled a Type C meeting with the FDA for March 2020 regarding a Phase 3 trial of its SLS-002 intranasal racemic ketamine for the treatment of acute suicidal ideation and behavior (ASIB) in patients with major depressive disorder (MDD). The FDA granted Fast Track designation to SLS-002 in November 2019. According to the … [Read more...] about Seelos Therapeutics sets Type C meeting with FDA regarding SLS-002 intranasal racemic ketamine

According to Savara, the FDA has granted Breakthrough Therapy designation for Molgradex inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). In June 2019, Savara announced that the Phase 3 IMPALA study of Molgradex for that indication had failed to meet its … [Read more...] about FDA grants Breakthrough Therapy designation for Molgradex for aPAP

AstraZeneca has announced that its PT010 budesonide/glycopyrronium/formoterol fumarate MDI has been approved by the Chinese National Medical Products Administration for the treatment of COPD. PT010 was approved in Japan as Breztri Aerosphere in June 2019. According to AstraZeneca, the approval was based on results from the Phase 3 KRONOS trial, which had a primary … [Read more...] about AstraZeneca’s triple combination MDI approved in China for treatment of COPD

According to Evoke Pharma, the company has resubmitted its 505(b)(2) for Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis. Evoke originally submitted the NDA for Gimoti in in June 2018 and announced that the FDA had issued a complete response letter to that NDA in April 2019. The company said that the resubmitted NDA includes new … [Read more...] about Evoke resubmits NDA for Gimoti nasal spray

Australia's Therapeutic Goods Administration has approved Ryaltris olopatadine hydrochloride/mometasone furoate nasal spray for the treatment of allergic rhinitis and rhinoconjunctivitis, Glenmark Pharmaceuticals said. The marketing application was submitted by Seqirus, which acquired Australian commercialization rights to the nasal spray in July 2018. Glenmark said … [Read more...] about Ryaltris nasal spray approved in Australia

The European Commission has approved Janssen Pharmaceutical's Spravato esketamine nasal spray for the treatment of treatment-resistant major depressive disorder, the company said. The EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion regarding the MAA for Spravato in October 2019. The FDA approved Spravato for the same … [Read more...] about Spravato approved in Europe