Hikma announces US FDA approval of KLOXXADOTM (naloxone hydrochloride) nasal spray 8mg
Important new option for reversing opioid overdoses
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LONDON, April 30, 2021 /PRNewswire/ Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces the approval of KLOXXADO
TM (naloxone hydrochloride) nasal spray 8mg, by the US Food and Drug Administration (FDA) for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients.
KLOXXADO
TM contains twice as much naloxone per spray as Narcan
® Nasal Spray 4mg in a ready-to-use nasal spray to reverse the effects of opioid overdose, providing an important new treatment option in addressing the opioid epidemic.
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LONDON, April 28, 2021 /PRNewswire/ Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces it has signed an exclusive license and distribution agreement with AFT Pharmaceuticals (AFT) for the commercialisation of Combogesic
® IV, the US trade name of Maxigesic IV, an intravenous, opioid free post-operative pain relief medicine.
The licensing agreement provides Hikma with exclusive rights for the sales, marketing and distribution of Combogesic
® IV in the US. Combogesic
® IV (paracetamol 1000mg + ibuprofen 300mg solution for infusion) is a patented intravenous formulation developed as a line extension to Maxigesic tablets, for use post-operatively in hospitals when patients cannot take a medicine orally. AFT expects to file Combogesic
Hikma announces exclusive agreement with AFT Pharmaceuticals for injectable non-opioid pain medication Combogesic® IV in the US prnewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from prnewswire.com Daily Mail and Mail on Sunday newspapers.
Hikma resumes launch of generic Advair Diskus®
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LONDON, April 20, 2021 /PRNewswire/ Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces that it has resumed the launch of its generic version of GlaxoSmithKline s Advair Diskus
®1 in the US following US FDA approval of an amendment Hikma submitted to its Abbreviated New Drug Application in January 2021. The amendment reflected enhanced packaging controls to meet new industry standards adopted since the initial submission of its ANDA.
Hikma will immediately resume launch activities of its generic product for Advair Diskus
® (Fluticasone Propionate and Salmeterol Inhalation Powder, USP), 100mcg/50mcg and 250mcg/50mcg doses in the US.
Hikma launches generic Advair Diskus® following FDA approval
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LONDON, Dec. 17, 2020 /PRNewswire/ Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces it has received FDA approval for and launched its generic version of GlaxoSmithKline s Advair Diskus
®1 (Fluticasone Propionate and Salmeterol Inhalation Powder, USP), 100mcg/50mcg and 250mcg/50mcg doses in the US.
Hikma worked with Vectura Group, a UK based provider of innovative inhaler drug delivery solutions, to develop the proprietary dry powder inhaler and formulation technology.
According to IQVIA, US sales of Fluticasone Propionate and Salmeterol Inhalation Powder USP, 100mcg/50mcg and 250mcg/50mcg, were approximately $2 billion in the 12 months ending September 2020.