usfda

Latest stories

  • in Health care

    USFDA authorizes second Omicron-updated COVID booster for older adults

    by

    US: The U.S. Food and Drug Administration on Tuesday authorized a second dose of Omicron-targeting COVID-19 vaccines for older adults as well as those with a weak immune system. The agency also said the updated shots from Pfizer-BioNTech and Moderna would become the new primary COVID vaccine, and withdrew its emergency-use authorization for the older messenger RNA […] More

  • in Health care

    USFDA nod to Roche’s Polivy in combination with R-CHP for certain types of previously untreated diffuse large B-cell lymphoma

    by

    Basel: Roche has announced that the U.S. Food and Drug Administration (FDA) has approved Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an […] More

  • in Health care

    Zydus Lifesciences bags USFDA nod for pulmonary drug Roflumilast

    by

    Ahmedabad: Pharma major, Zydus Lifesciences Limited, has announced that the company has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Roflumilast Tablets, 250 mcg (USRLD: Daliresp Tablets, 250 mcg). Roflumilast reduces inflammation in the lungs which leads to chronic obstructive pulmonary disease (COPD). It is used to […] More

  • in Health care

    Piramal Pharma gets USFDA EIR for Sellersville facility

    by

    Mumbai: Piramal Pharma has recently announced that the US Food and Drug Administration (USFDA) has successfully concluded the inspection of the company’s manufacturing facility located at Sellersville, USA and has issued an Establishment Inspection Report (EIR) for the said facility. EIR is the final inspection report of an FDA inspection. The inspection was held between December 19, […] More

  • in Health care

    USFDA nod to Zydus Lifesciences Estradiol Transdermal System for postmenopausal osteoporosis prevention

    USFDA approves Zydus Lifesciences Tavaborole Topical Solution to treat fungal toenail infections

    by

    Ahmedabad: Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Estradiol Transdermal System USP, 0.014 mg/day (weekly) (USRLD: Menostar Transdermal System). Estradiol transdermal system is indicated for prevention of postmenopausal osteoporosis. The drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, […] More

  • in Health care

    Zydus Lifesciences bags USFDA okay for Isoproterenol Hydrochloride Injection

    Zydus Lifesciences bags USFDA okay for Isoproterenol Hydrochloride Injection

    by

    Ahmedabad: Drugmaker, Zydus Lifesciences Limited, has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Isoproterenol Hydrochloride Injection USP, 0.2 mg/mL and 1 mg/5 mL (0.2 mg/mL) single-dose vials (USRLD: Isuprel Injection). Isoproterenol hydrochloride injection is indicated to improve hemodynamic status in patients in distributive shock and shock […] More

  • in Health care

    USFDA clears reader for Abbott FreeStyle Libre 3 system

    USFDA clears reader for Abbott FreeStyle Libre 3 system

    by

    Abbott Park, Ill.: Abbott has announced that the U.S. Food and Drug Administration (FDA) has cleared a reader for its FreeStyle Libre 3 integrated continuous glucose monitoring (iCGM) system, which features the smallest, thinnest and most discreet glucose sensor. “With the FDA’s clearance of a standalone reader, Abbott is working to get the FreeStyle Libre 3 system added […] More

  • in Health care

    USFDA approves Zydus Lifesciences Tavaborole Topical Solution to treat fungal toenail infections

    USFDA approves Zydus Lifesciences Tavaborole Topical Solution to treat fungal toenail infections

    by

    Ahmedabad: Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Tavaborole Topical Solution, 5% (USRLD: Kerydin Topical Solution). Tavaborole topical solution is indicated to treat fungal toenail infections. These are the infections that may cause nail discoloration, splitting, or pain. The drug will be […] More

  • in Health care

    Shilpa Medicare Psoriatic arthritis drug Apremilast gets USFDA okay

    Shilpa Medicare Psoriatic arthritis drug Apremilast gets USFDA okay

    by

    Karnataka: Shilpa Medicare has recently announced that the Company has received final approval from the U.S Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Apremilast Tablets, 10 mg, 20 mg, and 30 mg. The medicine is indicated for the treatment of adult patients with active psoriatic arthritis. Psoriatic arthritis is a long-term inflammatory arthritis. It occurs in individuals […] More

  • in Health care

    Zydus Lifesciences bags USFDA nod for Azithromycin Tablets to treat certain bacterial infections

    Zydus Lifesciences bags USFDA nod for Azithromycin Tablets to treat certain bacterial infections

    by

    Ahmedabad: Drugmaker, Zydus Lifesciences Limited, has announced that the company has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Azithromycin Tablets USP, 500 mg (USRLD: Zithromax Tablets). Azithromycin is indicated to treat certain bacterial infections such as bronchitis, pneumonia, sexually transmitted diseases (STD), infections of the ears, […] More

Load More
Congratulations. You've reached the end of the internet.