• The US Food and Drug Administration (FDA) has accepted for review Teva Pharmaceutical's Biologics License Application (BLA) for reslizumab for the treatment of inadequately controlled asthma in adult and adolescent patients with elevated blood eosinophils, despite an inhaled corticosteroid (ICS)-based regimen.

  • The US Food and Drug Administration (FDA) has approved Novartis' Promacta (eltrombopag) for the treatment of children six years and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Promacta was approved by the FDA in 2008 for use in adult patients with the same condition.

  • Jubilant Life Sciences Limited is an integrated global pharmaceutical and life sciences company engaged in manufacture and supply of APIs, generics, specialty pharmaceuticals and life science ingredients. It also provides services in contract manufacturing and drug discovery.  US Food and Drug Administration (USFDA) upgraded Jubilant Hollisterstier's pharmaceutical sterile manufacturing facility in Spokane, Washington (USA)  to the status of Voluntary Action Indicated (VAI). This upgradation by the USFDA from Official Action Indicated (OAI) to VAI is indicative of the cGMP status at the facility since receiving the warning letter in 2013.

  • 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 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.

  • 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.

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