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Regulatory

Padagis launches generic of Narcan naloxone nasal spray

Padagis, formerly Perrigo's generic prescription pharmaceutical business, has announced the launch of a generic version of Narcan naloxone nasal spray for the reversal of opioid overdose. The Padagis generic is the second approved in the US since the FDA's initial approval of Narcan in 2015. Teva’s version of Narcan was approved by the FDA in April 2019 and was … [Read more...] about Padagis launches generic of Narcan naloxone nasal spray

Savara’s molgramostim gets Innovation Passport from the MHRA

Savara announced that the UK Medicines and Healthcare Products Regulatory Agency has awarded an Innovation Passport to molgramostim inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). The Innovation Passport provides entry into the agency's Innovative Licensing and … [Read more...] about Savara’s molgramostim gets Innovation Passport from the MHRA

Opiant begins rolling NDA submission for OPNT003 intranasal nalmefene

Opiant Pharmaceuticals said that it has filed the first part of a 505(b)(2) NDA for OPNT003 intranasal nalmefene for the treatment of opioid overdose and that it expects to complete the submission later this year. The company recently announced that a PD study of OPNT003 met its primary endpoint. Opiant President and CEO Roger Crystal commented, "The opioid … [Read more...] about Opiant begins rolling NDA submission for OPNT003 intranasal nalmefene

FDA clears IND for Codagenix intranasal RSV vaccine

According to Codagenix, the FDA has cleared the company's IND for CodaVax-RSV intranasal live-attenuated vaccine (LAIV) for the prevention of respiratory syncytial virus (RSV) infection, and plans are in progress for a Phase 1 study in children aged 6 months to 5 years. Codagenix previously conducted a Phase 1 study of CodaVax-RSV in adults aged … [Read more...] about FDA clears IND for Codagenix intranasal RSV vaccine

FDA accepts Avillion’s NDA for PT027 albuterol/budesonide MDI

According to Avillion, the FDA has accepted the company's NDA for AstraZeneca's PT027 albuterol/budesonide MDI for the treatment of asthma in patients aged 4 and older for review. In March 2018, Avillion announced that it was partnering with Pearl Therapeutics on development of PT027; Pearl was acquired by AstraZeneca in 2013. AstraZeneca has an option to … [Read more...] about FDA accepts Avillion’s NDA for PT027 albuterol/budesonide MDI

FDA approves Tyvaso DPI for the treatment of PAH and PH-ILD

United Therapeutics has announced the FDA's approval of its NDA for Tyvaso treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). United Therapeutics licensed Treprostinil Technosphere from MannKind Corporation in September 2018 and submitted the NDA for Tyvaso DPI in … [Read more...] about FDA approves Tyvaso DPI for the treatment of PAH and PH-ILD

Blue Lake’s intranasal RSV vaccine gets Fast Track designation

According to CyanVac subsidiary Blue Lake Biotechnology, the FDA has granted Fast Track designation for the company's BLB-201 intranasal vaccine against respiratory syncytial virus (RSV) in children under 2 and adults over 60. The vaccine is based on an attenuated strain of canine parainfluenza virus (PIV5). In March 2022, Blue Lake announced that the FDA had … [Read more...] about Blue Lake’s intranasal RSV vaccine gets Fast Track designation

FDA accepts Biohaven’s NDA for intranasal zavegepant for the treatment of migraine

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

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

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