Milestone Pharmaceuticals says that it held a Type A meeting with the FDA following receipt of a Refuse to File letter in December 2023 in response to the company's NDA for etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). According to Milestone, the agency did not request any additional clinical trials. The company says that … [Read more...] about Milestone says it will resubmit its NDA for etripamil nasal spray
Regulatory
United Therapeutics sues the FDA alleging improper handling of Liquidia’s sNDA for Yutrepia treprostinil DPI
In addition to ongoing litigation against Liquidia Corporation alleging infringement of patents covering Tyvaso inhaled treprostinil by Liquidia's Yutrepia treprostinil DPI, United Therapeutics Corporation announced that it is now suing the FDA over its handling of Liquidia's sNDA to add PH-ILD as an indication for Yutrepia. United Therapeutics calls the sNDA … [Read more...] about United Therapeutics sues the FDA alleging improper handling of Liquidia’s sNDA for Yutrepia treprostinil DPI
ARS Pharma announces results of Neffy intranasal epinephrine study, plans to file response to CRL
ARS Pharmaceuticals said that it intends to file a response to the September 2023 complete response letter to its NDA for Neffy epinephrine nasal spray “early in the second quarter of 2024,” with the response supported by data from a repeat dose study with nasal allergen challenge as requested by the FDA. According to ARS, topline results from the study, which … [Read more...] about ARS Pharma announces results of Neffy intranasal epinephrine study, plans to file response to CRL
Apotex recalls two lots of APO-Mometasone nasal spray
Health Canada has announced that Apotex is recalling 2 lots of its mometasone nasal spray, a generic of Nasonex, due to possible contamination with Burkholderia cepacia complex. Lot TX5343 has an expiration date of September 2025, and lot TZ2586 has an expiration date in October 2025. APO-Mometasone nasal spray is approved in Canada for the treatment of allergies … [Read more...] about Apotex recalls two lots of APO-Mometasone nasal spray
Krystal Biotech’s KB707 inhaled gene therapy for the treatment of lung tumors gets Fast Track designation
Krystal Biotech announced that inhaled KB707 gene therapy for the treatment of metastasized tumors in the lung that are not successfully treated with standard therapy has been granted Fast Track designation by the FDA. The FDA had previously granted Fast Track designation to intra-tumoral KB707 for the treatment of melanoma. In July 2023, Krystal announced that it … [Read more...] about Krystal Biotech’s KB707 inhaled gene therapy for the treatment of lung tumors gets Fast Track designation
Lupin launches cyanocobalamin nasal spray in US
Lupin announced that it has launched its generic cyanocobalamin nasal spray for the prevention and treatment of vitamin B12 deficiency in the US. The FDA approved the company's ANDA for the 500 mcg/spray intranasal cyanocobalamin in June 2023. The Lupin cyanocobalamin nasal spray is a generic of Par Pharmaceutical's Nascobal nasal spray, which was approved by the … [Read more...] about Lupin launches cyanocobalamin nasal spray in US
Microbion’s pravibismane gets orphan drug designation for NTM indication
Microbion Corporation announced that the FDA has granted orphan drug designation for pravibismane for the treatment of non-tuberculous mycobacterial (NTM) infections. Pravibismane, which Microbion is developing as a topical treatment as well as an inhalation suspension, already had orphan drug designation for the treatment of lung infections in cystic fibrosis … [Read more...] about Microbion’s pravibismane gets orphan drug designation for NTM indication
Defender gets CRL in response to its DPI-386 intranasal scopolamine NDA
Defender Pharmaceuticals announced that the FDA has issued a complete response letter in response to the NDA for DPI-386 scopolamine nasal gel that the company submitted in July 2023. The FDA accepted the NDA for review in September 2023, with a PDUFA goal date of January 26, 2024. Defender President and CEO Barry I. Feinberg commented, “Following our review of … [Read more...] about Defender gets CRL in response to its DPI-386 intranasal scopolamine NDA
Liquidia announces that the FDA will miss the PDUFA goal date for review of Yutrepia sNDA to add PH-ILD indication
According to Liquidia Corporation, the FDA has informed the company that the agency will not meet the PDUFA goal date of January 24, 2004 for completion of the review of Liquidia's sNDA to add an indication for pulmonary hypertension associated with interstitial lung disease (PH-ILD) for Yutrepia treprostinil DPI. The company said that the FDA "informed the Company … [Read more...] about Liquidia announces that the FDA will miss the PDUFA goal date for review of Yutrepia sNDA to add PH-ILD indication
FDA issues CRL to Satsuma’s NDA for STS101 intranasal dry powder DHE for the treatment of migraine
According to Satsuma Pharmaceuticals parent company Shin Nippon Biomedical Laboratories, the FDA has issued a complete response letter to Satsuma's NDA for STS101 dihydroergotamine nasal powder for the treatment of migraine. SNBL said that the CRL cited CMC issues only and did not request any additional clinical data or new clinical trials. The company added that it … [Read more...] about FDA issues CRL to Satsuma’s NDA for STS101 intranasal dry powder DHE for the treatment of migraine