A child-size dose of an HIV drug is one step closer to being available in Europe...
A child-size dose of an HIV drug is one step closer to being available in Europe.
The drug, Abbott's lopinavir/ritonavir (Kaletra), is already available in an adult dose of 200 mg/50 mg, respectively. The halved pediatric dose, 100 mg/25 mg, has already been approved by FDA.
The EU's Committee for Medicinal Products of Human Use, which works with the World Health Organization, approved the new dosage. The approval brings with its a Certificate of Pharmaceutical Product, which lets the new dosage to be approved in many developing countries. Abbott markets Kaletra at a reduced price in developing countries as Aluvia.
Both the old and new dosages do not need refrigeration, and can be taken with or without food. EMEA (European Medicines Agency) approval of the drug is expected within 90 days.
FDA issues second CRL for dasiglucagon to treat hypoglycemia in congenital hyperinsulinism
Published: October 8th 2024 | Updated: October 8th 2024This decision marks the second time the FDA has issued a complete response letter (CRL) for dasiglucagon to treat hypoglycemia in patients 7 days and up with congenital hyperinsulinism.