According to Biohaven Pharmaceuticals, the FDA has accepted the company's NDA for its zavegepant (BHV-3500) calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the treatment of migraine and has set a PDUFA goal date in the first quarter of 2023. In December 2019, Biohaven announced positive results from a Phase 2/3 pivotal trial of the nasal … [Read more...] about FDA accepts Biohaven’s NDA for intranasal zavegepant for the treatment of migraine
Regulatory
Alembic gets FDA approval for its arforoterol tartrate inhalation solution
According to Indian generics developer Alembic Pharmaceuticals, the company's ANDA for a generic version of Sunovion's Brovana arformoterol tartrate inhalation solution for the treatment of COPD has received final FDA approval. Alembic co-developed the arformoterol inhalation solution with Indian CRO Orbicular Pharmaceutical Technologies. The ANDA approval is … [Read more...] about Alembic gets FDA approval for its arforoterol tartrate inhalation solution
Evoke gets new drug product exclusivity for Gimoti nasal spray
Evoke Pharma announced that the FDA has granted new drug product exclusivity for Gimoti metoclopramide nasal spray, giving the company exclusive marketing rights for 3 following the initial approval date. The FDA approved Gimoti for the treatment of diabetic gastroparesis in June 2020. The company also noted that it has two patents covering Gimoti listed in the … [Read more...] about Evoke gets new drug product exclusivity for Gimoti nasal spray
Zambon’s CMS I-neb inhaled colistimethate sodium gets Breakthrough Therapy designation
The FDA has granted Breakthrough Therapy designation to Zambon's CMS I-neb colistimethate sodium for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult patients with chronic P. aeruginosa lung infections, the company said. The FDA had previously granted QIDP and Fast Track designations to the colistimethate sodium powder, which is delivered as a … [Read more...] about Zambon’s CMS I-neb inhaled colistimethate sodium gets Breakthrough Therapy designation
FDA allows additional MS patients in intranasal Foralumab expanded access program
Tiziana Life Sciences said that the FDA has issued a Study May Proceed letter allowing Brigham and Women’s Hospital (BWH) to treat an additional eight patients with secondary progressive multiple sclerosis (SPMS) with Tiziana's intranasal Foralumab under an Intermediate-Size Patient Population Expanded Access IND. The agency evaluated data from treatment of two … [Read more...] about FDA allows additional MS patients in intranasal Foralumab expanded access program
FDA clears IND for Blue Lake intranasal RSV vaccine
CyanVac subsidiary Blue Lake Biotechnology is planning a Phase 1 trial of its BLB-201 intranasal vaccine against respiratory syncytial virus (RSV) after receiving FDA clearance for its IND, CyanVac said. The Phase 1 trial will evaluate BLB-201 in two different cohorts, one aged 18-59 and the other aged 60-75. According to the company, preclinical studies of BLB-201 in … [Read more...] about FDA clears IND for Blue Lake intranasal RSV vaccine
Ji Xing gets go-ahead for Phase 3 trial of OC-01 varenicline nasal spray for dry eye disease in China
According to Ji Xing Pharmaceuticals, Chinese regulators have approved the company's application for a Phase 3 clinical trial of OC-01 varenicline nasal spray for the treatment of dry eye disease in China. Ji Xing acquired the Chinese rights to OC-01 and OC-02 simpinicline nasal spray for the treatment of dry eye disease from Oyster Point Pharma in August 2021. In the … [Read more...] about Ji Xing gets go-ahead for Phase 3 trial of OC-01 varenicline nasal spray for dry eye disease in China
FDA approves Rx-to-OTC switch for Perrigo’s Nasonex 24HR Allergy nasal spray
According to Perrigo, the FDA has approved its NDA for Nasonex 24HR Allergy mometasone furoate nasal spray for the treatment of allergy symptoms, the first branded Rx-to-OTC switch for Perrigo, and the company expects to launch Nasonex 24HR Allergy sometime in 2022. In 2018, the company announced that it had acquired US rights to an OTC version of Nasonex from Merck. … [Read more...] about FDA approves Rx-to-OTC switch for Perrigo’s Nasonex 24HR Allergy nasal spray
FDA approves Mylan (Viatris) generic of Symbicort MDI (updated)
The FDA has approved a generic version of AstraZeneca's Symbicort budesonide / formoterol fumarate MDI from Mylan (now Viatris), the agency announced. The FDA tentatively approved the Mylan ANDA in March 2021 just after a court had ruled in favor of AstraZeneca in its suit against Mylan and Kindeva Drug Delivery (formerly 3M Drug Delivery). In December 2021, an … [Read more...] about FDA approves Mylan (Viatris) generic of Symbicort MDI (updated)
Tonix Pharmaceuticals provides updates on TNX-1900 and TNX-2900 intranasal oxytocin
Tonix Pharmaceuticals has provided updates on two formulations of its intranasal potentiated oxytocin. The company acquired the license for one of the formulations, TNX-1900 for the treatment of migraine, from Trigemina in June 2020. According to the announcement, Massachusetts General Hospital will conduct a Phase 2 trial of TNX-1900 for the treatment of binge … [Read more...] about Tonix Pharmaceuticals provides updates on TNX-1900 and TNX-2900 intranasal oxytocin