Regulatory
-
Florida-based Breckenridge Pharmaceutical has announced the launch of its azelastine HCl nasal spray, a generic version of Meda’s Astelin, after receiving final FDA approval of its ANDA. The product is approved for the treatment of… Read more . . .
-
Allergan has confirmed that it submitted an Abbreviated New Drug Application (ANDA) with the FDA for a generic version of United Therapeutics’ Tyvaso treprostinil inhalation solution for the treatment of pulmonary arterial hypertension and says… Read more . . .
-
Two days after Adapt Pharma announced that it had submitted an NDA for Narcan naloxone nasal spray, Indivior has announced that the FDA has accepted its naloxone nasal spray NDA for priority review. Indivior says… Read more . . .
-
Adapt Pharma has submitted an NDA for Narcan naloxone nasal spray for the treatment of opioid overdose to the FDA, the company has announced. In June 2015, Adapt said that it had initiated a rolling… Read more . . .
-
Propeller Health has received 510(k) clearance from the FDA to market the Propeller inhaler monitoring platform for use with the Diskus DPI and with the Respimat SMI, the company announced. Two versions of the Propeller… Read more . . .
-
The FDA has approved Amneal Pharmaceuticals’s generic version of Tobi tobramycin inhalation solution, the company said. The product is the New Jersey-based generic pharmaceutical company’s first inhalation solution. Amneal co-CEO and Chairman Chirag Patel said,… Read more . . .
-
The FDA has issued product-specific recommendations for demonstrating the bioequivalence of over 40 drug products, including several OINDPs. The newly added documents include guidances for azelastine HCL/fluticasone propionate nasal spray, budesonide/formoterol fumarate MDI, and levalbuterol… Read more . . .
-
According to Boehringer Ingelheim, the United Kingdom, Croatia, Slovakia, Denmark, Norway, Ireland, Austria, Romania and Spain have approved the Spiolto Respimat tiotropium/olodaterol SMI for the treatment of COPD. BI recently announced the launch of the… Read more . . .
-
The Canadian Agency for Drugs and Technology in Health (CADTH) has issued a call for patient input regarding GSK’s Breo Ellipta fluticasone furoate/vilanterol DPI for the treatment of asthma. According to the announcement, the agency… Read more . . .
-
The Israeli Patent Office has issued Patent No. 193318, “System for Pulmonary Delivery of Alpha-1 Proteinase Inhibitor,” to Kamada and PARI Pharma, Kamada has announced. The patent relates to delivery of Kamada’s inhaled alpha-1 proteinase… Read more . . .
Upcoming Events
Sponsored by Intertek
Want information about upcoming OINDP-related events delivered directly to your inbox? click here
October 21-October 22: MVIC Symposium, Lund, Sweden
November 10-November 11: Rescon Europe 2026, Porto, Portugal
December 9-December 11: DDL 2026, Edinburgh, Scotland