USFDA

The U.S. Food and Drug Administration  approved Vistogard (uridine triacetate) for the emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil or capecitabine, or who develop certain severe or life-threatening toxicities within four days of receiving these cancer treatments.

Teva Pharmaceutical Industries Ltd announced that the U.S. Food and Drug Administration’s (FDA) Pulmonary-Allergy Drugs Advisory Committee recommended approval of reslizumab, a humanized anti-interleukin-5 (IL-5) IgG4K monoclonal antibody (mAb), in adult patients aged 18 years and older. Reslizumab is a targeted biologic therapy for the treatment of inadequately controlled asthma in patients with elevated blood eosinophils, despite an inhaled corticosteroid (ICS)-based treatment regimen.

U.S. Food and Drug Administration cleared for marketing in the United States the first cooling cap to reduce hair loss in female breast cancer patients undergoing chemotherapy.

Teva Pharmaceutical Industries Ltd. and Eagle Pharmaceuticals, Inc.  announced that the U.S. Food and Drug Administration (FDA) has approved BENDEKA™, (bendamustine hydrochloride) injection, a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine. BENDEKA is approved for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Efficacy in CLL relative to first-line therapies other than chlorambucil has not been established.

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U.S. Food and Drug Administration approved Kanuma (sebelipase alfa) as the first treatment for patients with a rare disease known as lysosomal acid lipase (LAL) deficiency. Kanuma is produced by Alexion Pharmaceuticals Inc., based in Cheshire, Connecticut.

Baxalta Incorporated, a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, announced today that the U.S. Food and Drug Administration (FDA) has approved VONVENDI [von Willebrand factor (Recombinant)]. VONVENDI is the first and only recombinant treatment for adults living with von Willebrand Disease (VWD).

Drug firm Aurobindo Pharma has received final approval of the US health regulator to manufacture and market its Dexamethasone Sodium Phosphate injection, used to treat various conditions such as severe allergic reactions, arthritis and blood diseases.

Pfizer  announced that the U.S. Food and Drug Administration (FDA) has approved QuilliChew ER chewable tablets. Pfizer now offers two different products for the treatment of ADHD in patients ages 6 years old and above – liquid Quillivant XR® (methylphenidate HCl) CII and new QuilliChew ER chewable tablets.

The United States Food and Drug Administration (FDA) has granted Fast Track designation to Trevena's oliceridine (TRV130) for the management of moderate-to-severe acute pain. Oliceridine is being developed as a potential replacement for currently approved intravenous opioid analgesics.

AbbVie, a global biopharmaceutical company, announced its New Drug Application (NDA) has been accepted by the U.S. Food and Drug Administration (FDA) for a once-daily, fixed-dose formulation of the components of VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets). VIEKIRA PAK is an all-oral, interferon-free treatment approved with or without ribavirin (RBV) in the United States for patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including those with compensated cirrhosis. VIEKIRA PAK is not for people with decompensated cirrhosis.