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.
Amneal's risperidone extended-release injectable suspension approved by US FDA
First FDA acceptance to waive clinical efficacy studies for monoclonal antibody biosimilars
Coya Therapeutics wins FDA clearance to advance COYA 302 into Phase 2 ALS trial
Viatris' generic iron sucrose injection gains US FDA approval
Newbury Pharmaceuticals gains Finnish approval for generic melatonin
CivicaScript to distribute biosimilar for chronic inflammatory conditions
Mallinckrodt and Endo complete merger
Zenara Pharma's Sertraline Hydrochloride Capsules generic receives US FDA approval
EQT agrees to acquire majority stake in Adalvo
Mallinckrodt receives Irish High Court ruling to combine with Endo Inc
Accord Healthcare introduces Dehydrated Alcohol Injection for cardiovascular indications
CivicaScript introduces low-cost multiple sclerosis treatment
Breckenridge Pharmaceutical's generic for Ablysinol granted final FDA approval
Glenmark Therapeutics launches Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC)
AB Science secures Canadian patent for AB8939, completing global IP coverage for AML treatment