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
Regulatory
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
Savara to modify Phase 2/3 Molgradex trial to qualify as pivotal study in US
The IMPALA Phase 2/3 trial for Savara's Molgradex inhaled molgramostim for the treatment of autoimmune pulmonary alveolar proteinosis (PAP) will be modified in order to qualify as a pivotal study for a US regulatory submission, the company said. According to Savara, the FDA has provided guidance on increasing enrollment and changing endpoint hierarchy and analysis … [Read more...] about Savara to modify Phase 2/3 Molgradex trial to qualify as pivotal study in US
Evoke Pharma reports agreement with FDA regarding PK trial design for Gimoti
According to Evoke Pharma, the company has reached an agreement with the FDA on design of a PK trial for its Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis. The company said that results of the PK trial are expected later this year, with an NDA submission expected no later than early 2018. The company has previously announced that the … [Read more...] about Evoke Pharma reports agreement with FDA regarding PK trial design for Gimoti
Mylan gets complete response letter for generic Advair ANDA
Mylan has announced that it received a complete response letter from the FDA in regards to its ANDA for a generic version of GlaxoSmithKline's Advair Diskus fluticasone/salmeterol DPI. The company said that it is reviewing the CRL and will comment further once it has discussed it with the FDA. In February 2016, Mylan announced that the FDA had accepted its ANDA for … [Read more...] about Mylan gets complete response letter for generic Advair ANDA
FDA responds to Sandoz’s citizen petition on Advair bioequivalence recommendations
The FDA has denied a citizen petition filed by Sandoz in October 2016 in which Sandoz challenged the agency's 2013 bioequivalence recommendations for generic versions of Advair Diskus fluticasone propionate/salmeterol xinafoate. However, in a copy of the March 10, 2017 response letter posted by Fierce Pharma, the FDA said that it "has made no final determination … [Read more...] about FDA responds to Sandoz’s citizen petition on Advair bioequivalence recommendations
FDA approves Lupin’s generic TOBI inhalation solution
Lupin announced that the FDA has granted final approval for the company's tobramycin inhalation solution, a generic version of Novartis's TOBI 300 mg/5 ml inhalation solution for the treatment of P. aeruginosa lung infections in cystic fibrosis patients. The company noted that US sales of tobramycin inhalation solution in 2016 totaled $133.6 million. Read the … [Read more...] about FDA approves Lupin’s generic TOBI inhalation solution