-
Janssen Announces Approval of SPRAVATO for Major Depressive Disorder with Acute Suicidal Ideation
americanpharmaceuticalreview
August 10, 2020
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for SPRAVATO® (esketamine) CIII nasal spray, taken with an oral antidepressant.
-
FDA Authorizes First Tests that Estimate Antibodies from Past SARS-CoV-2 Infection
americanpharmaceuticalreview
August 10, 2020
The U.S. Food and Drug Administration (FDA) authorized the first two COVID-19 serology tests that display an estimated quantity of antibodies present in the individual’s blood.
-
Unichem gets US FDA approval for Tolterodine Tartrate tablets
expresspharma
August 07, 2020
These tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
-
FDA finalises guidance, ‘Limited Population Pathway for Antibacterial and Antifungal Drugs’
expresspharma
August 07, 2020
This guidance is intended to assist sponsors in developing labelling, including prescribing information, patient labelling, and carton/container labelling for drugs approved under the LPAD pathway.
-
Indoco gets USFDA approval for Olanzapine tablets
expresspharma
August 07, 2020
Olanzapine is indicated for the treatment of schizophrenia and bipolar disorder.
-
Lupin, Concord, receive US FDA approval for Mycophenolate Mofetil tablets USP
expresspharma
August 07, 2020
They are indicated for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants.
-
FDA approves IND for PSC’s stem cell therapy candidate for Covid-19
pharmaceutical-business-review
August 06, 2020
Calidi Biotherapeutics said that the Investigational New Drug (IND) application submitted by its partner, Personalized Stem Cells, Inc. (PSC), has received FDA approval for the treatment of COVID-19 and pneumonia patients using stem cell therapy.
-
ReViral secures FDA fast track status for sisunatovir to treat severe RSV infection
pharmaceutical-business-review
August 06, 2020
Clinical-stage biopharmaceutical company ReViral has secured fast track designation from the US Food and Drug Administration (FDA) for its sisunatovir to treat patients with serious respiratory syncytial virus (RSV) infection.
-
Alembic Pharma receives USFDA approval for Vardenafil Hydrochloride tablets
expresspharma
August 06, 2020
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Vardenafil Hydrochloride Tablets, 2.5 mg (base), 5 mg (base), 10 mg (base), and 20 mg (base).
-
FDA issues warning over subpotent and dangerous hand sanitisers
europeanpharmaceuticalreview
August 05, 2020
The FDA has updated its list of hand sanitisers to not use, including those with low levels of ethyl alcohol or isopropyl alcohol or with a dangerous presence of methanol.