Regulatory

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 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

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

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

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

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

According to ARS Pharmaceuticals, the FDA has extend the PDUFA target date for completion of its review of ARS's NDA for Neffy epinephrine nasal spray for the treatment of allergic reactions. The agency accepted the NDA for review in October 2022 and at that time, ARS said that the PDUFA date had been set for "mid-2023." The company says that the new PDUFA date … [Read more...] about FDA extends the PDUFA target date for review of ARS’s NDA for Neffy intranasal epinephrine

China Medical System Holdings announced that the National Medical Products Administration of China has approved the company's NDA for diazepam nasal spray for the treatment of seizure clusters in epilepsy patients age 6 and older when the seizures are different for the patient's usual pattern of seizures. In the US, the diazepam nasal spray, which is marketed as … [Read more...] about NMPA approves China Medical System’s NDA for diazepam nasal spray for the treatment of seizures