Regulatory

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 . . .

According to Lupin, Health Canada has approved the company’s generic version of Boehringer Ingelheim’s Spiriva tiotropium bromide inhalation powder for the treatment of COPD. In the UK, the MHRA approved the company’s Lutio tiotropium DPI… Read more . . .

The FDA has approved Indivior’s Opvee nalmefene nasal spray (OPNT003) for the treatment of opioid overdose, the company announced. Indivior recently acquired the intranasal nalmefene product as part of its acquisition of Opiant Pharmaceuticals. The… Read more . . .

The FDA recently published a new product specific draft guidance for inhaled dry powder loxapine for development of generic versions of Adasuve loxapine inhalation powder, which was approved by the agency in December 2012 for… Read more . . .

Satsuma Pharmaceuticals said that the FDA has accepted the company’s 505(b)(2) NDA for STS101 nasal powder dihydroergotamine for the treatment of migraine, and Satsuma expects the agency to set a PDUFA goal date in January… Read more . . .