[ad_1] Biocon Ltd on Monday said its arm Biocon Pharma Ltd has received approval from the US health regulator for its generic version of Everolimus tablets for oral suspension used in the treatment of tuberous sclerosis complex, a rare genetic disease that causes non-cancerous tumors or lesions in different parts of the body. The approval…
[ad_1] New Delhi: Drug firm Granules India on Monday said it has received approval from the US health regulator to market a generic medication for attention deficit hyperactivity disorder. Granules Pharmaceuticals Inc, a wholly-owned subsidiary of the company, has received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug…
[ad_1] New Delhi: Drug maker Lupin on Friday said it has received approval from the US health regulator to market a generic drug for the treatment of multiple sclerosis. The company has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application for Siponimod Tablets in strengths of…
[ad_1] Zydus Lifesciences Ltd on Friday said it has received final approval from the US health regulator for its generic version of Leuprolide Acetate injection used in palliative treatment of advanced prostatic cancer. The approval by the US Food and Drug Administration (USFDA) is for Leuprolide Acetate injection of strengths 14 mg/2.8 ml (1 mg/0.2…
[ad_1] Drug maker Lupin on Friday said it has launched a generic medication to treat schizophrenia in the US with 180 days of exclusivity. The company has launched Risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial, and 50 mg per vial, single-dose vials, with 180-day CGT exclusivity in the US,…
[ad_1] Alembic Pharmaceuticals Ltd on Monday said it has received final approval from the US health regulator for its generic version of Sumatriptan injection used in treatment of migraine. The approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) Sumatriptan Injection of strengths 4 mg/0.5 ml and…
[ad_1] Alembic Pharmaceuticals Ltd on Friday said it has received final approval from the US health regulator for its generic version of Dasatinib tablets used to treat certain types of blood cancer. The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Dasatinib Tablets of strengths…
[ad_1] Zydus Lifesciences Ltd on Monday said it has received final approval from the US health regulator for its generic version of Deflazacort oral suspension used in treating a severe form of inherited muscular dystrophy. The approval by the US Food and Drug Administration (USFDA) is for Deflazacort oral suspension of strength 22.75 mg/ml, Zydus…
[ad_1] Drug firm Wockhardt on Wednesday said it has submitted a new drug application for its novel antibacterial drug with the US health regulator. The company has submitted a New Drug Application (NDA) to the US Food and Drug Administration (USFDA) for its novel antibacterial agent Zidebactam-Cefepime injection, the Mumbai-based drugmaker said in a regulatory…
[ad_1] Pharma firm Caplin Point Laboratories Ltd on Wednesday said its arm Caplin Steriles Ltd has received final approval from the US health regulator for its generic milrinone lactate in 5 per cent dextrose injection indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. The approval granted by the US Food…