According to Tiziana Life Sciences, the FDA has cleared the company's IND to allow clinical development of intranasal foralumab in Alzheimer's disease. Earlier this year, Tiziana announced plans to develop foralumab, an intranasal anti-CD3 monoclonal antibody, for the treatment of Alzheimer's and Type 1 diabetes. The company is also developing intranasal foralumab for … [Read more...] about FDA clears Tiziana’s IND for intranasal foralumab in Alzheimer’s disease
Regulatory
Marinomed’s Carragelose nasal spray gets marketing authorization in Mexico
Marinomed Biotech said that its partner M8 Pharmaceuticals has received marketing authorization for Carragelose iota-carrageenan nasal spray in Mexico. M8 acquired the rights to market the nasal spray in Mexico and Brazil in 2021. According to the announcement, the product will be marketed in Mexico as "Barlo," with a launch "envisaged for the next season." … [Read more...] about Marinomed’s Carragelose nasal spray gets marketing authorization in Mexico
Defender Pharmaceuticals submits NDA for DPI-386 scopolamine nasal gel for the prevention of motion sickness
Defender Pharmaceuticals announced that it has submitted an NDA for its DPI-386 scopolamine nasal gel for the prevention of motion sickness in adults. According to the company's web site, Defender has worked with the US Navy and with the National Aeronautics and Space Administration (NASA) on development of DPI-386. Epiomed Therapeutics, which was founded by … [Read more...] about Defender Pharmaceuticals submits NDA for DPI-386 scopolamine nasal gel for the prevention of motion sickness
FDA approves Harm Reduction’s RiVive naloxone nasal spray
The FDA announced that it has approved Harm Reduction Therapeutic's NDA for RiVive naloxone nasal spray for the reversal of opioid overdose. Harm Reduction initiated a rolling NDA submission for RiVive in October 2022, and the agency accepted the NDA for priority review in December 2022. RiVive is approved for OTC sales; however, Harm Reduction's web site says that … [Read more...] about FDA approves Harm Reduction’s RiVive naloxone nasal spray
Liquidia submits sNDA for Yutrepia treprostinil DPI to add PH-ILD indication
Liquidia Corporation announced that it has submitted an sNDA for its Yutrepia treprostinil DPI, which was tentatively approved by the FDA in November 2021 for the treatment of pulmonary arterial hypertension (PAH). The supplemental application is for the use of Yutrepia to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD). According to … [Read more...] about Liquidia submits sNDA for Yutrepia treprostinil DPI to add PH-ILD indication
Lupin’s tiotropium bromide DPI approved in Australia
According to Lupin, the company's generic version of Boehringer Ingelheim's Spiriva Handihaler tiotropium bromide DPI has been approved for the treatment of COPD by Australia's Therapeutic Goods Administration (TGA). Lupin said that it will manufacture the inhalation powder at its plant in Pithampur, India. The company's generic version of Spiriva Handihaler has … [Read more...] about Lupin’s tiotropium bromide DPI approved in Australia
FDA approves OTC switch for Padagis’s generic of Narcan naloxone nasal spray
The FDA has approved Padagis's supplemental application for over-the-counter sales of the company's generic version of Narcan naloxone nasal spray, 4 mg, for the reversal of opioid overdose. Padagis initially launched its generic in the US in June 2022. In February 2023, an FDA advisory committee in favor of over-the-counter use of Narcan, and the agency approved … [Read more...] about FDA approves OTC switch for Padagis’s generic of Narcan naloxone nasal spray
Pendopharm recalls one lot of Rhinaris Nasal Mist in Canada
Health Canada announced that Pharmascience's Pendopharm division is recalling one lot of Rhinaris Nasal Mist saline nasal spray after "testing showed that the preservative in the product may not be as effective as expected." Specifically, the agency said that testing indicated the potential for P. aeruginosa to grow in the product. The lot affected by the recall is … [Read more...] about Pendopharm recalls one lot of Rhinaris Nasal Mist in Canada
FDA approves Lupin’s ANDA for cyanocobalamin nasal spray
According to Lupin, the FDA has approved the company's ANDA for a generic version of Par Pharmaceutical's Nascobal single dose cyanocobalamin nasal spray. Lupin said that it will manufacture the nasal spray at its plant in Somerset, NJ, USA. The FDA approved the NDA for Nascobal single dose nasal spray for the treatment of pernicious anemia and other vitamin B12 … [Read more...] about FDA approves Lupin’s ANDA for cyanocobalamin nasal spray
FDA approves Lupin’s generic of Spiriva HandiHaler tiotropium bromide DPI
Lupin announced that the FDA has approved the company's ANDA for its generic of Boehringer Ingelheim's Spiriva HandiHaler tiotropium bromide inhalation powder. Health Canada approved the company's tiotropium DPI earlier this year. In the UK, the DPI was approved in August 2022. According to Lupin, the company manufactures the product at its site in Pithampur, … [Read more...] about FDA approves Lupin’s generic of Spiriva HandiHaler tiotropium bromide DPI