Public health company The US Food and Drug Administration (FDA) reported on Friday that it has issued warning letters to operators of two websites, http://www.hydroxychloroquine-online.com and http://www.pharmaboosters.com, that market unapproved COVID-19 products.
On 15 July 2020, the agency said it approved an abbreviated new drug application, or generic, for heparin sodium, which is an anti-coagulant to prevent blood clotting. It has recognized the increased demand for certain products during the COVID-19 public health emergency and remains deeply committed to facilitating access to medical products to help address critical needs of the American public.
The FDA has issued Emergency Use Authorizations to Boston Heart Diagnostics for its molecular Boston Heart COVID-19 RT-PCR Test and to to Luminex Corporation for its serology xMAP SARS-CoV-2 Multi-Antigen IgG Assay.
To date, the agency has currently authorized 184 tests under EUAs including 152 molecular tests, 30 antibody tests and two antigen tests.
ScinoPharm Taiwan secures first US FDA approval for complex multiple sclerosis generic
ScinoPharm Taiwan's Glatiramer Acetate Injection approved by US FDA
International Isotopes Inc to change name to Radnostix Inc
Galmed Pharmaceuticals reports topline results for combination of Aramchol, Stivarga and metformin
Ingenus Pharmaceuticals' generic equivalent to Premarin receives US FDA approval
EirGenix signs second global exclusive licensing deal with Sandoz
Padagis invests USD36m to expand manufacturing in Minneapolis
Newbury Pharmaceuticals gains Danish approval for generic ivermectin cream