Regulatory

The FDA has announced the publication of a batch of new and revised product specific guidances for development of generic versions of a number of drugs, including a number of inhaled and nasal drug products, . One of the new guidances is for generic sumatriptan succinate nasal powder. Onzetra Xsail intranasal sumatriptan was approved by the FDA in January 2016 for … [Read more...] about FDA issues new and revised product specific guidances for a number of generic OINDPs

Virpax Pharmaceuticals has announced the successful completion of a pre-IND meeting with the FDA regarding the company's NES100 intranasal enkephalin formulation for the management of acute and chronic pain. NES100 is a molecular envelope technology (MET) formulation licensed from Nanomerics and is delivered via a cartridge-based device. In January 2020, Virpax … [Read more...] about Virpax announces completion of pre-IND meeting for its intranasal enkephalin

GSK and Innoviva have announced that the EMA accepted a regulatory submission to expand the use of Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI to add the treatment of asthma in adults as an indication. Trelegy Ellipta has been approved in Europe for the treatment of COPD since November 2017. A previous Type II variation application was approved in … [Read more...] about EMA accepts GSK submission to expand use of Trelegy Ellipta to asthma

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