Regulatory

Dr. Reddy's subsidiary Promius Pharma has submitted an NDA for its DFN-02 intranasal sumatriptan for the treatment of migraine headaches, the company said. The DFN-02 formulation includes Aegis Therapeutics' Intravail absorption enhancer; Aegis received a US patent for formulations of triptans including Intravail in 2012. In June 2016, Promius announced that a … [Read more...] about Promius Pharma submits NDA for intranasal sumatriptan for migraine headaches

Insmed has submitted an NDA for ALIS amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC), the company said. In September 2017, Insmed announced that it would seek accelerated approval for ALIS from the FDA based on positive results from the Phase 3 CONVERT … [Read more...] about Insmed submits NDA for ALIS for the treatment of NTM lung infections caused by MAC

According to Adherium, the FDA has okayed over-the-counter (OTC) sales of the company's Smartinhaler sensor for AstraZeneca’s Symbicort MDI. The 510(k) OTC clearance will allow patients to purchase the sensor without a prescription at local pharmacies or online. In 2015, Adherium announced that it had partnered with AstraZeneca to provide sensors for use in the … [Read more...] about Adherium’s Smartinhaler SmartTouch for Symbicort sensor gets 510(k) OTC clearance

Acorda Therapeutics has submitted a marketing authorization application to the EMA for its Inbrija levodopa DPI for the treatment of OFF periods in Parkinson's disease patients, the company said. The application is supported by data from the Phase 3 SPAN-PD trial, which demonstrated improved motor function in Parksinson's patients experiencing OFF periods, and … [Read more...] about Acorda files MAA for Inbrija inhaled levodopa

Orion Corporation has announced that its salmeterol/fluticasone Easyhaler combination DPI has received a positive opinion under the EU's decentralized procedure, with Sweden as the reference member state. Orion had announced in December 2016 that it planned to submit an MAA in early 2017 based on positive results from a PK study. According to Orion, it will now … [Read more...] about Orion gets positive opinion for salmeterol/fluticasone Easyhaler in EU under the decentralized procedure

According to Hikma Pharmaceuticals, the FDA has concluded the dispute resolution process regarding HIkma's ANDA for its generic version of the Advair fluticasone propionate/salmeterol DPI and has requested a new clinical study. The FDA issued a complete response letter to the ANDA in May 2017. The company affirmed that it "remains committed to bringing this … [Read more...] about FDA requests additional clinical trial for Hikma’s generic Advair

Aradigm has submitted a marketing authorization application to the EMA for Linhaliq dual release inhaled ciprofloxacin for the treatment of chronic P. aeruginosa lung infections in non-cystic fibrosis bronchiectasis (NCFBE) patients, the company said. In January 2018, the FDA issued a CRL for Aradigm's NDA for Linhaliq. According to Aradigm, the MAA is supported by … [Read more...] about Aradigm submits MAA for Linhaliq

A Type II variation application for the use of the Relvar Ellipta fluticasone furoate/vilanterol DPI in patients whose asthma is adequately controlled by an ICS/LABA combination has been approved by the EC, according to GSK and Innoviva. The application was submitted in July 2017, and the EMA's Committee for Medicinal Products for Human Use (CHMP) issued a … [Read more...] about Label update for Relvar Ellipta approved by EC

AstraZeneca has announced that the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) has voted to recommend the use of FluMist Quadrivalent intranasal live Influenza vaccine for the 2018-19 flu season based on positive results of a new study in children aged 2-4 years old. FluMist Quadrivalent was approved by the … [Read more...] about FluMist Quadrivalent intranasal flu vaccine gets renewed recommendation