Regulatory
-
Milestone Pharmaceuticals announced that it has resubmitted its NDA for etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). The FDA had issued a Refuse to File letter in December 2023 in response to… Read more . . .
-
The US Federal Trade Commission (FTC) recently filed an amicus brief in a patent infringement case filed by Teva against Amneal after Amneal submitted an ANDA for a generic version of Teva’s ProAir HFA albuterol MDI in… Read more . . .
-
According to Tonix Pharmaceuticals, the FDA has granted Rare Pediatric Disease Designation to TNX-2900 intranasal potentiated oxytocin for the treatment of Prader-Willi syndrome (PWS) in children and adolescents. Tonix licensed TNX-2900 from the French National… Read more . . .
-
According to Optinose, the FDA has approved the company’s sNDA to extend use of Xhance fluticasone propionate nasal spray to include the treatment of chronic sinusitis without nasal polyps. Xhance was approved by the FDA for… Read more . . .
-
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… Read more . . .
-
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… Read more . . .
-
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… Read more . . .
-
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… Read more . . .
-
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… Read more . . .
-
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… Read more . . .
Upcoming Events
Sponsored by Intertek
Want information about upcoming OINDP-related events delivered directly to your inbox? click here
December 9-December 11: DDL 2026, Edinburgh, Scotland
April 27-30: RDD Europe 2027, Antibes, France
May 12-13: USP Joint Workshop: Quality and Product Performance Testing of Orally Inhaled and Nasal Drug Products, Rockville, MD, USA
June 30: RespireX 2027, Boston, MA, USA