Glenmark Pharmaceuticals Inc., USA (Glenmark) get final approval by the United States Food & Drug Administration (FDA) for calcipotriene cream, 0.005 per cent, the therapeutic equivalent of Dovonex cream, 0.005 per cent of Leo Pharma A/S. Glenmark strategy to start to shipping of calcipotriene cream, 0.005 per cent immediately.
The US Food and Drug Administration (FDA) has granted orphan-drug designation to biopharmaceutical company MediciNova Inc.'s MN-166 (ibudilast) for treatment of Krabbe disease. MediciNova previously opened an Investigational New Drug (IND) application with the Division of Neurology Products (DNP) for MN-166 (ibudilast).
The US FDA has granted approval to Cipla's Lopinavir, Ritonavir (LPV/r) 40mg/ 10 mg oral pellets for paediatric specific treatment of HIV in infants. Cipla was working for many years in collaboration with Diana Gibb, professor of epidemiology, senior programme leader and honorary consultant paediatrician at Medical Research Council Clinical Trials Unit at UCL (University College London) towards development of this novel child-friendly formulation which has been approved by US FDA under the President’s Emergency Plan for AIDS Relief (PEPFAR) programme. This product is a first step in making accessible more modern and appropriately formulated treatment available to the most vulnerable of HIV patients – young children.
Glenmark Pharmaceuticals granted tentative approval by the US health regulator to sell Rufinamide, which is used to treat seizures caused by Lennox-Gastaut syndrome.
In the United States every year nearly 90,000 women are diagnosed with some gynecological cancer. These include cancer of the cervix, uterus, ovaries, vagina, and vulva. These women undergo treatments including radiation, chemotherapy and surgery. A University of Colorado Cancer Center study presented at the American Society for Clinical Oncology (ASCO) Annual Meeting 2015 has shown sexual dysfunction in women following gynecologic cancer treatment. The study shows decreased sexual activity in women following treatment for gynecologic cancers, down from 6.1-6.8 times per month before treatment to 2.6-4.9 times per month after treatment.
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US Food and Drug Administration (FDA) has approved Eli Lilly and Company Humalog 200 units/mL KwikPen (insulin lispro 200 units/mL; U-200), a pre-filled pen containing a concentrated formulation of Lilly's rapid-acting insulin Humalog (insulin lispro 100 units/mL) Humalog U-200 KwikPen is used to improve glycemic control in people with type 1 and type 2 diabetes.
The Food and Drug Administration (FDA) has approved Actavis' Viberzi (eluxadoline) as a twice-daily, oral treatment for adults suffering from irritable bowel syndrome with diarrhoea (IBS-D).
IBS-D is a multifactorial disorder marked by recurrent abdominal pain or discomfort and altered bowel function that affects as many as 15 million adult Americans, impacting about twice as many women as men. There are few treatment options available for IBS-D, particularly options that relieve both the diarrhea and abdominal pain associated with IBS-D.
US Food and Drug Administration (FDA) has approved Neupogen, a drug originally used to treat side effects of chemotherapy,is the first ever approved for the treatment of acute radiation injury and the approval came as a result of research performed by the University of Maryland School of Medicine (UM SOM) scientists.
The US Food and Drug Administration (FDA) granted Orphan Drug Designation to Aura Biosciences' drug AU-011 for the treatment of uveal melanoma. The FDA’s Orphan Drug Designation programme provides orphan status to drugs and biologics, which demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions in the US.
Strides Arcolab Limited has got approval from the United States Food & Drug Administration (FDA) for lamivudine and zidovudine tablets USP, 150 mg/300 mg for HIV therapy.
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