According to Lannett, the FDA has set a GDUFA goal date of January 31, 2022 for completion of its review of the ANDA for Respirent's generic version of Advair Diskus fluticasone propionate / salmeterol DPI for the treatment of asthma and COPD. The submission of the ANDA was announced in April 2021 by Lannett, which acquired US rights to the generic version of … [Read more...] about FDA sets goal date for review of Lannet’s ANDA for generic of Advair Diskus
Regulatory
EMA says there is insufficient evidence that treatment with ICS can benefit COVID-19 patients
The EMA’s COVID-19 task force has said "that there is currently insufficient evidence that inhaled corticosteroids are beneficial for people with COVID-19." In addition, the task force said that "it could not exclude the possibility of harm from the use of inhaled corticosteroids in patients with COVID-19 who have normal levels of oxygen." Evidence cited by the … [Read more...] about EMA says there is insufficient evidence that treatment with ICS can benefit COVID-19 patients
MHRA approves Nasacort nasal spray for general sale
The UK Ministry of Healthcare Products Regulatory Agency (MHRA) announced that it has approved an application from Aventis Pharma (Sanofi) to reclassify Nasacort Allergy Relief triamcinolone acetonide nasal spray for the treatment of allergic rhinitis in patients aged 18 and over from a pharmacy (P) medicine to a general sales list (GSL) product. Nasacort was approved … [Read more...] about MHRA approves Nasacort nasal spray for general sale
Liquidia resubmits NDA for LIQ861 treprostinil DPI
Liquidia has announced the resubmission of its NDA for LIQ861 dry powder treprostinil for the treatment of pulmonary arterial hypertension, with the addition of CMC and device data requested by the FDA. Liquidia initially submitted the 505(b)(2) NDA in January 2020; the FDA accepted the submission for review in April 2020; and in November 2020, the agency issued a … [Read more...] about Liquidia resubmits NDA for LIQ861 treprostinil DPI
FDA approves Hikma’s Kloxxado naloxone nasal spray
The FDA has approved a 505(b)(2) NDA for Hikma's Kloxxado naloxone nasal spray for the reversal of opioid overdose. Hikma says that it expects to launch the nasal spray, which was approved for use in pediatric and adult patients, in the second half of this year. Kloxxado delivers 8 mg of naloxone per dose, twice as much as the higher dose of Narcan naloxone nasal … [Read more...] about FDA approves Hikma’s Kloxxado naloxone nasal spray
Health Canada approves the Syqe medical cannabis inhaler
Health Canada has approved Syqe Medical's metered dose medical cannabis inhaler, the company said. The Syqe inhaler, which uses a cartridge pre-loaded with granulated cannabis, has been available to patients in Israel since June 2019. In September 2019, the company announced that it had signed a deal with TerrAscend for distribution of the device in … [Read more...] about Health Canada approves the Syqe medical cannabis inhaler
Ryaltris nasal spray approved in the EU
Glenmark Pharmaceuticals said that it plans to launch Ryaltris olopatadine / mometasone furoate nasal spray for the treatment of allergic rhinitis in 16 European Union countries and the UK after finalizing marketing approval. Menarini Group will commercialize Ryaltris in some of the companies, including France, Italy, Spain, and the Balkans, under a December 2020 … [Read more...] about Ryaltris nasal spray approved in the EU
Chiesi gets EC approval for Trimbow Nexthaler triple combination DPI for the treatment of COPD
The European Commission has approved Chiesi's Trimbow Nexthaler extrafine beclometasone dipropionate / formoterol fumarate / glycopyrronium DPI for the treatment of moderate to severe COPD in patients not adequately treated with an ICS/LABA or LABA/LAMA combination, the company said. Chiesi's Trimbow triple combination MDI was approved in Europe for the treatment … [Read more...] about Chiesi gets EC approval for Trimbow Nexthaler triple combination DPI for the treatment of COPD
Hikma re-starts launch of its generic version of Advair Diskus
Hikma Pharmaceuticals said that the FDA has approved an amendment to the company's ANDA for its generic version of Advair Diskus fluticasone propionate / salmeterol DPI, and the company has subsequently restarted the launch of the inhaler. The FDA initially approved the ANDA in December 2020, and the company said that it was launching the DPI at that time. Hikma … [Read more...] about Hikma re-starts launch of its generic version of Advair Diskus
United Therapeutics submits NDA for Tyvaso DPI
United Therapeutics said that it has submitted an NDA for its Tyvaso treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH) and has applied a priority review voucher that it acquired for $105 million in December 2020. With the use of the priority review voucher, the FDA could issue a decision regarding the NDA by the end of 2021. In 2018, … [Read more...] about United Therapeutics submits NDA for Tyvaso DPI