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
Regulatory
Aradigm submits MAA for Linhaliq
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
Label update for Relvar Ellipta approved by EC
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
Ventolin, Seretide Diskus/Accuhalers recalled in multiple countries
Less than a week after GSK Canada said that it had recalled a lot of Ventolin Diskus in Canada due to “a manufacturing issue that may result in a small number of Ventolin Diskus devices not delivering the full number of doses in the device,” the MHRA announced a recall of 2 lots of Ventolin Accuhaler and 1 lot of Seretide Accuhaler in the UK due to the same issue. … [Read more...] about Ventolin, Seretide Diskus/Accuhalers recalled in multiple countries
FluMist Quadrivalent intranasal flu vaccine gets renewed recommendation
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
Insmed gets additional US patent for ALIS amikacin liposome inhalation suspension
The US Patent and Trademark Office has issued US Patent Number 9,895,385, titled "Methods for treating pulmonary non-tuberculous mycobacterial infections" to Insmed Incorporated, the company said. According to Insmed, the patent is the 9th for ALIS and extends patent coverage for the formulation from January 2034 to May 2035. The patent covers the use of nebulized … [Read more...] about Insmed gets additional US patent for ALIS amikacin liposome inhalation suspension
FDA accepts Acorda’s new NDA for Inbrija inhaled levodopa
The FDA has accepted Acorda Therapeutics' revised NDA for Inbrija inhaled levodopa for the treatment of symptoms associated with OFF periods in Parkinson’s disease in patients taking carbidopa/levodopa, the company said. The PDUFA target date is October 5, 2018. In August 2017, the FDA issued a refuse-to-file letter in response to Acorda's initial 505(b)(2 ) NDA … [Read more...] about FDA accepts Acorda’s new NDA for Inbrija inhaled levodopa
GSK submits type II variation application in Europe for expanded use of Trelegy Ellipta
GlaxoSmithKline and Innoviva have announced the submission of a type II variation application seeking expanded use for the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) DPI for the treatment of COPD. Trelegy Ellipta was granted marketing authorization in Europe in November 2017. In the US, the FDA initially approved Trelegy Ellipta for … [Read more...] about GSK submits type II variation application in Europe for expanded use of Trelegy Ellipta
Savara’s IND for Moldgradex study approved
According to Savara, the FDA has approved an IND the company submitted for Molgradex, an inhaled molgramostim (recombinant human GM-CSF) formulation for the treatment of autoimmune pulmonary alveolar proteinosis (PAP), which the company filed in December 2017. The approval allows the company to enroll patients in the ongoing Phase 3 IMPALA study at sites in the … [Read more...] about Savara’s IND for Moldgradex study approved
Dauntless Pharmaceuticals gets orphan drug designation for intranasal octreotide
The FDA has granted orphan drug designation to Dauntless Pharmaceuticals' DP1038 intranasal octreotide acetate for the treatment of acromegaly, the company said. Dauntless announced positive Phase 1 results for DP1038 in May 2015. Dauntless Pharmaceuticals President and CEO Joel Martin commented, "The FDA's decision to grant DP1038 orphan drug designation for the … [Read more...] about Dauntless Pharmaceuticals gets orphan drug designation for intranasal octreotide