USFDA

The U.S. Food and Drug Administration approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first drug in its class (IDH1 inhibitors) and is approved for use with an FDA-approved companion diagnostic used to detect specific mutations in the IDH1 gene in patients with AML.

Sun Pharmaceutical Industries Ltd announced that it has received approval from the U.S. Food and Drug Administration (USFDA) for INFUGEM™ (gemcitabine in 0.9% sodium chloride injection) 10 mg/mL, for intravenous use in a ready-to-administer (RTA) bag. This is the first USFDA approval for a product from Sun Pharma’s Halol facility post receipt of Establishment Inspection Report (EIR) in June 2018.

FDA considering all options for positively impacting both access and the cost of health care. FDA announcing a new effort to establish innovative approaches to increase access to a broader selection of nonprescription drug products for consumers, empowering them to self-treat common conditions and potentially some chronic conditions.

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Colesevelam Hydrochloride for Oral Suspension, 1.875 grams/Packet and 3.75 grams/Packet, the generic version of Welchol®1 for Oral Suspension, 1.875 grams/Packet and 3.75 grams/Packet, of Daiichi Sankyo Inc.

The U.S. Food and Drug Administration approved a new device, the Zephyr Endobronchial Valve (Zephyr Valve), intended to treat breathing difficulty associated with severe emphysema.

The U.S. Food and Drug Administration filed a complaint against Innovative BioDefense, Inc. of Lake Forest, California, and Colette Cozean, the company’s president and chief executive officer, to prohibit them from selling Zylast topical antiseptics with claims that they are effective against infection by pathogens such as norovirus, rotavirus, flu virus, Methicillin-Resistant Staphylococcus Aureus (MRSA), and Ebola. Claims that a hand sanitizer can protect consumers against infection from pathogens are drug claims and therefore, these products are regulated by the FDA as drugs. These products from Innovative BioDefense, Inc. have not been proven to be safe and effective for these uses and are not approved by the FDA.

The U.S. Food and Drug Administration is warning consumers that over-the-counter (OTC) teething products containing benzocaine pose a serious risk to infants and children. The agency announced that OTC oral health products containing the pain reliever benzocaine for the temporary relief of sore gums due to teething in infants or children should no longer be marketed and is asking companies to stop selling these products for such use. If companies do not comply, the FDA will initiate a regulatory action to remove these products from the market. Also, the agency is requesting that companies add new warnings to all other benzocaine oral health products to describe certain serious risks.

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The U.S. Food and Drug Administration approved Palynziq (pegvaliase-pqpz) for adults with a rare and serious genetic disease known as phenylketonuria (PKU). Patients with PKU are born with an inability to break down phenylalanine (Phe), an amino acid present in protein-containing foods and high-intensity sweeteners used in a variety of foods and beverages. Palynziq is a novel enzyme therapy for adult PKU patients who have uncontrolled blood Phe concentrations on current treatment.

The U.S. Food and Drug Administration  approved Doptelet (avatrombopag) tablets to treat low blood platelet count (thrombocytopenia) in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. This is the first drug approved by the FDA for this use.

The U.S. Food and Drug Administration  approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. The treatment is given by once-monthly self-injections. Aimovig is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks.