Regulatory

Evoke Pharma has announced that the FDA will allow the company to move forward with an NDA for its Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis without a human factors validation study, exempting the product from requirements set out in the 2016 guidance titled "Applying Human Factors and Usability Engineering to Medical … [Read more...] about FDA exempts Evoke’s Gimoti metoclopramide nasal spray from human factors requirement

The FDA has accepted OptiNose’s new drug application for its OPN-375 intranasal fluticasone for the treatment of nasal polyposis in adult patients, with an anticipated PDUFA date in September 2017, the company announced. OptiNose CEO Peter Miller commented, “The FDA acceptance of the new drug application for OPN-375 is a particularly exciting milestone for our … [Read more...] about FDA accepts OptiNose NDA for OPN-375 intranasal fluticasone

The FDA has approved the Symbicort budesonide/formoterol fumarate 80/4.5 μg MDI for the treatment of asthma in patients aged 6-12, AstraZeneca has announced. The company previously announced that it had received pediatric exclusivity for the product. Symbicort inhalation aerosol has been approved in the US for the treatment of asthma in patients 12 and up since … [Read more...] about Symbicort gets FDA approval for pediatric use

According to Teva Pharmaceutical Industries, the FDA has approved 3 strengths each for the AirDuo RespiClick fluticasone propionate/salmeterol DPI and the ArmonAir RespiClick fluticasone propionate DPI for the treatment of asthma in patients aged 12 and older. Both the AirDuo RespiClick and the ArmonAir RespiClick are approved for twice daily use and both are expected … [Read more...] about FDA approves Teva’s AirDuo RespiClick and ArmonAir Respiclick inhalers

AstraZeneca has announced that the FDA had granted 6 months of pediatric exclusivity for its Symbicort budesonide/formoterol MDI based on trials in asthmatic children aged 6-12. In August 2016, AstraZeneca announced that its CHASE 3 (ChildHood Asthma Safety and Efficacy) study met its primary endpoint and that it planned to submit the data to the FDA The Symbicort … [Read more...] about FDA grants pediatric exclusivity for Symbicort

Adapt Pharma announced that it has received FDA approval for a 2 mg dose version of Narcan naloxone nasal spray for the treatment of opioid overdose for opioid-addicted patients who would likely experience severe withdrawal if given the 4 mg dose. The 4 mg per dose formulation of Narcan was approved by the FDA in November 2015, and Adapt launched the nasal spray … [Read more...] about FDA approves lower dose formulation of Narcan nasal spray

According to Vectura, the FDA has approved the company's investigational new drug (IND) application for VR647 nebulized budesonide, which the company is developing for the treatment of asthma in children aged 12 months to 8 years. VR647 is delivered by the Akita Jet smart nebulizer, a technology that Vectura acquired in 2014, when it acquired Activaero. … [Read more...] about FDA approves IND for Vectura’s VR647 nebulized budesonide

According to Pulmatrix, its PUR1900 itraconazole DPI for the treatment of pulmonary aspergillus infections in cystic fibrosis patients has received Qualified Infectious Disease Product (QIDP) designation from the FDA. Pulmatrix CEO Robert Clarke commented, "The new QIDP designation is a significant boost to our efforts to make this drug available as quickly as … [Read more...] about Pulmatrix gets QIDP designation for PUR1900

Neurelis has announced that its NRL-1 intranasal diazepam has received Fast Track designation from the FDA for the treatment of acute repetitive or cluster seizures in epilepsy patients. The company plans to submit an NDA for the product by early 2018. The FDA granted NRL-1 orphan drug designation in 2015, and Neurelis announced the initiation of pivotal trials in … [Read more...] about Neurelis gets Fast Track designation for intranasal diazepam

Amphastar Pharmaceuticals subsidiary Armstrong Pharmaceuticals has received a complete response letter from the FDA in regard to its NDA for the Primatene Mist epinephrine inhaler, Amphastar has announced. The CRL said that the FDA would require an additional human factors validation study as well as label and packaging changes. The original version of Primatene … [Read more...] about Amphastar gets complete response letter for Primatene Mist