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 the generic version of ProAir HFA in 2012; Teva responded with a patent infringement suit. In 2014, the companies reached a settlement that would give Perrigo … [Read more...] about FDA approves Perrigo’s generic version of Teva’s ProAir albuterol MDI (updated)

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 were approved for twice daily inhalation: 55 mcg, 113 mcg and 232 mcg. The Digihaler device includes a built-in usage monitoring … [Read more...] about Teva’s ArmonAir Digihaler approved by the FDA

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 treatment of asthma and COPD. The budesonide/formoterol DPI will be available in 160 µg/4.5 μg and 320 μg/9 μg strengths. The … [Read more...] about CHMP recommends approval of Teva’s budesonide/formoterol DPI

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 2 trial of Pulmazole for that indication in July 2019. Pulmatrix CEO Ted Raad said, "Patients with asthma-ABPA have … [Read more...] about Pulmazole inhaled itraconazole for ABPA gets Fast Track designation

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 clinical benefits and cost effectiveness. NICE will accept comments on the draft guidance through its web site until February 18, … [Read more...] about NICE declines to recommend Spravato nasal spray for the treatment of treatment-resistant depression

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 trial of LIQ861 had met its primary endpoint. Liquidia CEO Neal Fowler commented, "The submission of the NDA for LIQ861 in the US is … [Read more...] about Liquidia submits NDA for LIQ861 treprostinil DPI for the treatment of PAH

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 pharmacies with or without a prescription. Lilly acquired worldwide rights to the intranasal glucagon formulation from Locemia, which is based in … [Read more...] about Baqsimi intranasal glucagon approved in Canada

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) NDA was submitted in June 2018, and the FDA issued a complete response letter to that NDA in April 2019. Evoke announced in December 2019 that it had … [Read more...] about FDA accepts resubmitted NDA for Gimoti nasal spray