Regulatory

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 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

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

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

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

According to Teva Pharmaceuticals Europe, the company has received marketing authorization in the EU for duplicate DPIs Seffalair Spiromax salmeterol xinafoate/ fluticasone propionate and BroPair Spiromax salmeterol xinafoate/ fluticasone propionate for the treatment for asthma in patients aged 12 and older. The company said that the Spiromax device "has been well … [Read more...] about Teva’s Seffalair Spiromax and BroPair Spiromax approved in Europe

Respirent has submitted an ANDA to the FDA for its fluticasone propionate / salmeterol xinafoate DPI in 100/50 μg, 250/50 μg, and 500/50 μg dose levels for the treatment of asthma and COPD, according to Lannett, which acquired US rights to the generic version of Advair Diskus in October 2019. Lannett said that the term of that deal has recently been extended to 12 … [Read more...] about Respirent submits ANDA for generic version of Advair Diskus