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,… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .