Regulatory

Mylan has announced that it received a complete response letter from the FDA in regards to its ANDA for a generic version of GlaxoSmithKline’s Advair Diskus fluticasone/salmeterol DPI. The company said that it is reviewing… Read more . . .

The FDA has denied a citizen petition filed by Sandoz in October 2016 in which Sandoz challenged the agency’s 2013 bioequivalence recommendations for generic versions of Advair Diskus fluticasone propionate/salmeterol xinafoate. However, in a copy… Read more . . .

Lupin announced that the FDA has granted final approval for the company’s tobramycin inhalation solution, a generic version of Novartis’s TOBI 300 mg/5 ml inhalation solution for the treatment of P. aeruginosa lung infections in… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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 . . .