Regulatory

The FDA has announced the approval of Perrigo’s ANDA for a generic of Teva’s ProAir HFA albuterol MDI for the treatment of asthma in patients 4 years old and older. Perrigo initially filed its ANDA for… Read more . . .

The FDA has approved Teva’s ArmonAir Digihaler fluticasone propionate DPI for the treatment of asthma in patients aged 12 and older, the company said. ArmonAir Respiclick was approved for that indication in January 2017. Three doses… Read more . . .

The EMA has announced that its Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion regarding a marketing authorization application submitted by Teva Pharma B.V. for a budesonide/formoterol DPI for the… Read more . . .

Pulmatrix has announced that its Pulmazole (PUR1900) dry powder itraconazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma has received Fast Track designation from the FDA. The company initiated a Phase… Read more . . .

The UK’s National Institute for Health and Care Excellence (NICE) has announced that it is not recommending the use of Janssen’s Spravato esketamine nasal spray for the treatment of treatment-resistant depression due to concerns about… Read more . . .

Liquidia Technologies said that it has submitted a 505(b)(2) NDA for its LIQ861 inhaled dry powder treprostinil for the treatment of pulmonary arterial hypertension (PAH). The company announced in March 2019 that the Phase 3 INSPIRE… Read more . . .

Health Canada has approved Baqsimi intranasal dry powder glucagon for the treatment of severe hypoglycemia in patients with Type 1 or Type 2 diabetes, Eli Lilly Canada has announced. Baqsimi is now available in Canadian… Read more . . .

According to Evoke Pharma, the FDA has accepted its resubmitted NDA for Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis and has set a PDUFA date of June 19, 2020. The original 505(b)(2)… Read more . . .