Regulatory
-
In the wake of the EMA’s recent recommendation against use the use of calcitonin nasal sprays due to an increased risk of cancer, Health Canada says that it is also evaluating the risks of calcitonin… Read more . . .
-
The FDA has approved Watson Pharmaceuticals’ Abbreviated New Drug Application (ANDA) for a generic version of Pulmicort Respules. The budesonide inhalation suspension 0.25mg/2mL and 0.5mg/2mL ampules are the subject of an ongoing patent dispute with… Read more . . .
-
Health Canada has issued an advisory to health care professionals that “AstraZeneca Canada has received a small number of product complaints for Pulmicort Turbuhaler, 200 µg per metered dose (200 doses) regarding the malfunction of… Read more . . .
-
Unigene Laboratories, which manufactures Fortical calcitonin nasal spray for the treatment of osteoporosis, has requested product safety data submitted to the EMA’s Committee for Medicinal Products for Human Use (CHMP) in response to the EMA’s… Read more . . .
-
Just after announcing the approval of the Tudorza Pressair aclidinium bromide dry powder inhaler for the treatment of COPD in the US, Almirall has announced that the European Commission has granted marketing approval to its… Read more . . .
-
The US House of Representatives held a meeting on July 18, 2012 regarding the “Asthma Inhalers Relief Act of 2012,” which is intended “To direct the Administrator of the Environmental Protection Agency to allow for… Read more . . .
-
The FDA has approved the Tudorza Pressair aclidinium bromide dry powder inhaler for the treatment of COPD. The DPI will be distributed by Forest Pharmaceuticals, a division of Forest Laboratories, which licensed US rights to… Read more . . .
-
According to Alexza Pharmaceuticals, the company has submitted responses to the Day 120 List of Questions it received from the EMA’s Committee for Medicinal Products for Human Use in March 2012 regarding its marketing application… Read more . . .
-
The FDA has issued a 483 to Exemplar citing observations regarding problems with MDI filling from its March 21, 2012 inspection of the company’s Massachusetts facility. Exemplar is referring inquiries about the issue to MAP… Read more . . .
-
The FDA has granted 510(k) clearance to Asthmapolis’s asthma sensor system and mobile app. The sensor attaches to the top of an MDI canister, records data from an accelerometer and GPS receiver, and transmits the… Read more . . .
Upcoming Events
Sponsored by Intertek
Want information about upcoming OINDP-related events delivered directly to your inbox? click here
May 10-May 14: RDD 2026, Phoenix, AZ, USA
May 15-May 16: ATS Respiratory Innovation Summit 2026, Orlando, FL, USA
May 17-May 20: ATS International Conference 2026, Orlando, FL, USA
June 10: SMI.London 2026, London, UK
July 13-July 16: 2026 ISAM Congress, Taipei, Taiwan