Regulatory

According to Cipla, its Sereflo fluticasone/salmeterol MDI, a generic version of Advair (Seretide), has been approved by the UK MHRA for the treatment of asthma, and the product will be launched by a partner in the UK within a few weeks. Cipla Ltd. Global CEO Umang Vohra commented, “We are extremely pleased with the approval of Sereflo in the UK. This is a … [Read more...] about Cipla’s Sereflo fluticasone/salmeterol MDI approved in UK

Easyhaler maker Orion Corporation has announced that it plans to submit a marketing authorization application in the EU for its salmeterol/fluticasone DPI for the treatment of asthma and COPD in the first half of 2017. The company said that its plan to submit the MAA is based on recently received positive results from a PK study. Orion Senior VP, Pharmaceutical … [Read more...] about Orion announces plan to submit MAA for salmeterol/fluticasone Easyhaler in 2017

In advertisements appearing in British nursing, pharmaceutical, and medical journals.the Prescription Medicines Code of Practice Authority (PMCPA), the administrator of the Association of the British Pharmaceutical Industry’s (ABPI) Code of Practice for the Pharmaceutical Industry, has called out AstraZeneca for misleading promotions of the Duaklir Genuair … [Read more...] about PMCPA accuses AstraZeneca of being misleading about Duaklir Genuair indications

Evoke Pharma says that it recently had a positive pre-NDA meeting with the FDA regarding clinical data to be included in its planned 505(b)(2) NDA for Gimoti intranasal metoclopramide for the treatment of diabetic gastroparesis in adult women. The meeting was the second regarding Gimoti. After the first meeting, Evoke announced that it planned to move ahead with … [Read more...] about Evoke Pharma reports positive pre-NDA meeting with FDA for intranasal metoclopramide

GlaxoSmithKline and Innoviva have announced that GSK has filed an MAA with the European Medicines Agency for its fluticasone furoate/umeclidinium/vilanterol DPI for the treatment of COPD. In November 2016, GSK submitted an NDA for the FF/UMEC/VI product in the US. GSK Head, Respiratory Therapy Area Unit, R&D, Dave Allen said, “Many patients with COPD are already … [Read more...] about GSK files regulatory submission for triple combination DPI in EU

GlaxoSmithKline and Innoviva have announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the 100/25 mcg strength of the Relvar Ellipta fluticasone furoate/vilanterol DPI for the treatment of COPD. Both the 100/25 mcg and 200/25 mcg strengths of Relvar Ellipta have been approved in Japan for the treatment of asthma since 2013. GSK … [Read more...] about Relvar Ellipta approved in Japan for the treatment of COPD

GlaxoSmithKline has submitted an NDA in the US for its fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg) dry powder inhaler for the treatment of COPD, according to an announcement from GSK and Innoviva. The product will be delivered by GSK's Ellipta device. Earlier this year, GSK announced that it would file the submission by the end of 2016 … [Read more...] about GSK submits NDA for triple combination DPI for COPD

Propeller Health has announced that its inhaler monitoring platform has received 510(k) clearance from the FDA for use with the Ellipta dry powder inhaler. The company had announced a deal with GSK to develop a sensor for the Ellipta DPI in December 2015. GSK Head of Respiratory R&D Dave Allen commented, "While it is still in the early stages of development, the … [Read more...] about Propeller Health inhaler monitoring platform gets 510(k) clearance for use with the Ellipta DPI

Fierce Pharma has published a copy of a citizen petition filed by Sandoz that challenges the FDA's recommendations for establishing bioequivalence for generic copies of Advair Diskus 100/50. The FDA published the draft guidance for fluticasone propionate/salmeterol xinafoate in September 2013. The Sandoz citizen petition, submitted October 13, 2016, contends that … [Read more...] about Sandoz files citizen petition challenging FDA Advair bioequivalence recommendations

The FDA's Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) has voted to recommend approval of Allergan's SER120 desmopressin nasal spray for the treatment of nocturia (needing to wake up to urinate at night) in adults. The vote was 17-1 on the question of whether at least one of the SER120 doses is effective and 14-4 on the question of whether the … [Read more...] about FDA committee recommends approval of Allergan’s SER120 desmopressin nasal spray