Regulatory

A February 17, 2017 FDA warning letter to Wockhardt subsidiary Morton Grove Pharmaceuticals cites numerous cGMP violations, including several related to the manufacture of fluticasone propionate nasal spray. Wockhardt's generic fluticasone propionate nasal spray was approved by the FDA in January 2012. The letter states that "During our inspection, we observed … [Read more...] about FDA warns Wockhardt subsidiary over fluticasone propionate nasal spray manufacturing and testing violations

The FDA has announced the approval of Noctiva desmopressin acetate nasal spray for the treatment of nocturnal polyuria (overproduction of urine at night). Allergan licensed SER120 desmopressin nasal spray from Serenity Pharmaceuticals in 2010. In 2007, the FDA announced that intranasal desmopressin was no longer indicated for the treatment of nocturnal enuresis … [Read more...] about FDA approves Noctiva desmopressin nasal spray for the treatment of nocturnal polyuria

Adapt Pharma has filed a marketing authorization application in Europe for its naloxone nasal spray for the treatment of opioid overdose, the company said. Adapt's naloxone nasal spray, marketed as Narcan, has been approved in the US since 2015 and in Canada since 2016. The FDA also approved a lower dose of formulation of Narcan in January 2017. Meanwhile, … [Read more...] about Adapt files MAA for its naloxone nasal spray, Amphastar gets CRL for its version

The FDA has approved Boehringer Ingelheim's sNDA for the use of Spiriva Respimat to treat asthma in patients aged 6 and older and has granted pediatric exclusivity for the product, the company announced. Spiriva Respimat was approved for the treatment of asthma in patients 12 and older in the US in September 2015. Boehringer Ingelheim Pharmaceuticals Senior VP, … [Read more...] about Spiriva Respimat approved by FDA for pediatric use

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