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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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,… Read more . . .

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… Read more . . .

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… Read more . . .