Regulatory

According to Vectura, its partner Hikma Pharmaceuticals has received a complete response letter from the FDA to its ANDA for VR315 fluticasone propionate/salmeterol DPI, a generic version of GSK’s Advair Diskus. Vectura said that the… Read more . . .

According to Evoke Pharma, the company has reached an agreement with the FDA on design of a PK trial for its Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis. The company said that… Read more . . .

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 . . .