USFDA

The U.S. Food and Drug Administration approved Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.

Sun Pharmaceutical Industries Limited announced that the U.S. Food and Drug Administration (US FDA) has approved SEZABY  (phenobarbital sodium powder for injection) for the treatment of neonatal seizures. With this approval, SEZABY becomes the first and only product specifically indicated in the U.S. for the treatment of neonatal seizures in term and preterm infants. SEZABY is expected to be available in the U.S. in Q4FY23.

Lupin Limited has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Drospirenone Tablets, 4 mg, to market a generic equivalent of Slynd Tablets, 4 mg, of Exeltis USA Inc.

Drospirenone is a progestin medication which is used as contraceptive to prevent pregnancy and in menopausal hormone therapy, among other uses.

Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ketorolac Tromethamine Injection USP, 15 mg/mL, 30 mg/mL, and 60 mg/2 mL (30 mg/mL) Single Dose Vials.

This is the second injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.

Novavax, Inc a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received emergency use authorization (EUA) from the U.S.

Lupin Biotech manufacturing facility in Pune receives 17 observations after prior approval inspection by US FDA.

The Company does not believe that the 483 letter will have an impact on the existing revenues from operations of this facility.

The U.S. FDA conducted a Prior-Approval Inspection at Lupin’s Biotech manufacturing facility in Pune, India in October 2022. The inspection concluded with the issuance of a Form 483 with seventeen observations.

GSK plc announced that the US Food and Drug Administration has approved a new presentation of Menveo [Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diptheria CRM197 Conjugate Vaccine] for individuals aged 10 to 55 years to help prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W. The Menveo one-vial presentation now comes in a ready to use single vial giving healthcare providers a more convenient option.

Zydus Lifesciences Limited’s (formerly known as Cadila Healthcare Limited) subsidiary Zydus Worldwide DMCC has received tentative approval from the United States Food and Drug Administration (USFDA) to market Valbenazine Capsules USP 40 mg, 60 mg, and 80 mg (USRLD: Ingrezza®) & Roflumilast Tablets USP, 250 mcg (USRLD: Daliresp®).

The U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose in younger age groups. The Moderna COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to six years of age.