TGA
Provisional determination for new COVID treatment
Sabizabulin’s sponsor can now seek provisional registration for the treatment of COVID-19, says the TGA The Therapeutic Goods Administration has announced that it has granted a provisional determination to Adjutor …
Downschedule decision on allergic rhinitis drugs
Bid to downschedule existing fixed-dose combination products containing both azelastine and fluticasone propionate rejected in interim decision An application to amend the existing S2 entries for azelastine and fluticasone propionate …
Blood pressure drug recall
Potential carcinogen traces prompts action as “precautionary measure” Pharmaceutical company Pfizer is recalling some batches of hypertension medications containing quinapril and pausing supply of others, according to an alert from …
TGA fines vape importer almost $3k
Individual accused of false customs declaration A person based in Western Australia has been fined $2,664 by the TGA for allegedly illegally importing liquid nicotine for vaping products. The infringement …
Ozempic shortages until December
Diabetes medication shortfall “worse than ever” The long-running shortage of diabetes drug Ozempic (semaglutide) looks set to continue until at least the end of the year, according to a revised …
Fines over COVID-19 masks, RATs
The Federal court has ordered one company to pay $80k over face mask breach, while another has been fined $67k for failing to provide information on its RATs The TGA …
TGA seeks advisory committee members
Its seven statutory committees will soon have 46 vacancies The Therapeutic Goods Administration is looking for applicants to join its seven advisory committees which consider the regulation of medicines, vaccines, …
Media wrong on RAT sensitivity: TGA
The TGA has clarified why several COVID-19 rapid antigen tests were removed from the market The Therapeutic Goods Administration has said in a statement that it is “aware of several …
TGA on the move
The TGA has begun court proceedings against a company selling vapes, while another company undertakes to comply with advertising rules for face masks The Therapeutic Goods Administration has commenced Federal …
Confronting ‘dire’ medicine shortages
With over 400 medicines facing shortages, the industry says it’s working to minimise the impact As medicines shortages continue to increase, Australian peak bodies say they are “deeply concerned” about …
Vaping fine handed down
TGA issues fine for over $30k for unlawful advertising The TGA has issued 12 infringement notices totalling $31,698 to a NSW-based individual for alleged unlawful advertising of disposable nicotine vaping …
A return to ‘pre-pandemic levels’
Shortages of intravenous and subcutaneous Actemra have been resolved as pharmacists thanked for their patience A shortage of Actemra (tocilizumab) has finally been resolved after supply was battered following recommendations …