Acorda Therapeutics has submitted a 505(b)(2) new drug application for Inbrija (CVT-301) levodopa for the treatment of symptoms during OFF periods in Parkinson's disease patients, the company said. According to the company, the FDA is expected to inform the company whether or not the application has been accepted by the end of September. In May 2017, Acorda … [Read more...] about Acorda submits NDA for Inbrija inhaled levodopa for Parkinson’s disease
Regulatory
Boehringer Ingelheim files citizen petition challenging GSK’s NDA for triple combination DPI
Boehringer Ingelheim has filed a citizen petition with the FDA asking the agency to "request the Commissioner of Food and Drugs to ensure that any New Drug Application (“NDA”) for a fixed-dose, triple-combination, inhaled drug product intended for the treatment of patients with chronic obstructive pulmonary disease (“COPD”) is not approved as safe and effective unless … [Read more...] about Boehringer Ingelheim files citizen petition challenging GSK’s NDA for triple combination DPI
Health Canada accepts Penthrox regulatory submission for review
Medical Developments International (MVP) has announced that Health Canada has accepted its submission for the Penthrox methoxyflurane inhaler, triggering a $250,000 Canadian milestone payment to MVP from Purdue Pharma Canada. In September 2016, MVP announced that Purdue Pharma Canada would pay $3 million Canadian for Canadian rights to Penthrox for the treatment of … [Read more...] about Health Canada accepts Penthrox regulatory submission for review
FDA accepts Sandoz’s ANDA for generic version of Advair Diskus
According to Novartis, the FDA has accepted Sandoz's abbreviated new drug application for its generic version of the Advair Discus (Seretide Accuhaler) fluticasone propionate/salmeterol DPI for the treatment of asthma and COPD. The company acquired the product when it acquired Oriel Therapeutics in 2010. In October 2016, Sandoz filed a citizen petition with the … [Read more...] about FDA accepts Sandoz’s ANDA for generic version of Advair Diskus
Pharmaxis announces results from Phase 3 trial of Bronchitol mannitol DPI for CF
Pharmaxis has announced that its pivotal Phase 3 trial of Bronchitol mannitol DPI in adult patients with cystic fibrosis met its primary endpoint of change in FEV1 from baseline over the 26-week treatment period; however the company said that the improvement was less than that reported in previous Phase 3 studies in adults. Pharmaxis, which is partnered with … [Read more...] about Pharmaxis announces results from Phase 3 trial of Bronchitol mannitol DPI for CF
Sunovion gets CRL for SUN-101/eFlow glycopyrrolate inhalation solution
According to Sunovion, the FDA has issued a complete response letter (CRL) for its NDA for SUN-101/eFlow glycopyrrolate inhalation solution for the treatment of COPD. Sunovion submitted the NDA for SUN-101/eFlow in July 2016, and the FDA accepted the application in October 2016, giving a PDUFA date of May 29, 2017. In response to the CRL, Sunovion said that it … [Read more...] about Sunovion gets CRL for SUN-101/eFlow glycopyrrolate inhalation solution
CHMP issues positive opinion on Chiesi’s Trimbow triple therapy inhaler
Chiesi Group has announced that the EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding the company's MAA for Trimbow beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide MDI. Chiesi has applied to market the extrafine formulation triple combination ICS/LABA/LAMA for the treatment of COPD. The Trimbow … [Read more...] about CHMP issues positive opinion on Chiesi’s Trimbow triple therapy inhaler
Acorda says it is preparing NDA and MAA for Inbrija inhaled L-dopa, will present new data from Phase 3 trial
Acorda Therapeutics will present new data from a Phase 3 trial of its CVT-301 inhaled L-dopa, which it is now calling Inbrija, at the International Congress of Parkinson’s Disease and Movement Disorders (MDS). The company has previously said that data from the Phase 3 SPAN-PD trial show that CVT-301 significantly improves motor function in Parkinson's Disease … [Read more...] about Acorda says it is preparing NDA and MAA for Inbrija inhaled L-dopa, will present new data from Phase 3 trial
EMA approves Takeda’s multidose Instanyl nasal spray with Aptar Pharma e-Lockout device
Aptar Pharma has announced that its partner Takeda Pharmaceuticals has received approval from the EMA to market a multidose version of its Instanyl fentanyl nasal spray that includes Aptar's e-Lockout integrated electronic lockout device. According to Aptar, Takeda plans to market the product as Instanyl DoseGuard, though no launch date has been announced at this … [Read more...] about EMA approves Takeda’s multidose Instanyl nasal spray with Aptar Pharma e-Lockout device
Hikma gets CRL for its generic version of Advair Diskus
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 CRL was categorized as "Major" and added, "Based on the initial assessment no material issues were raised regarding the substitutability … [Read more...] about Hikma gets CRL for its generic version of Advair Diskus