USFDA

U.S. Food and Drug Administration’s comprehensive framework for regulating nicotine and tobacco. FDA is developing policies that support the possibility of a world where combustible cigarettes could no longer create or sustain addiction. A key part of this framework are steps to pave the way for products that help currently addicted smokers move away from the deadliest form of nicotine delivery.

The U.S. Food and Drug Administration  issued new scientific recommendations aimed at encouraging more widespread innovation and development of novel medication-assisted treatment (MAT) drugs for the treatment of opioid use disorder (OUD). New draft guidance outlines new ways for drug developers to consider measuring and demonstrating the effectiveness and benefits of new or existing MAT products. This new draft guidance is part of the FDA’s ongoing commitment to promote more widespread development, access to and adoption of MAT.

The U.S. Food and Drug Administration approved Azedra (iobenguane I 131) injection for intravenous use for the treatment of adults and adolescents age 12 and older with rare tumors of the adrenal gland (pheochromocytoma or paraganglioma) that cannot be surgically removed (unresectable), have spread beyond the original tumor site and require systemic anticancer therapy. This is the first FDA-approved drug for this use.
Pheochromocytomas are rare tumors of the adrenal glands. These glands are located right above the kidneys and make hormones including stress hormones called epinephrines and norepinephrines.

The U.S. Food and Drug Administration  approved a magnetic device system for guiding lymph node biopsies in patients with breast cancer undergoing mastectomy. The Magtrace and Sentimag Magnetic Localization System (Sentimag System) uses magnetic detection during sentinel lymph node biopsy procedures to identify specific lymph nodes, known as sentinel lymph nodes, for surgical removal.

As part of its ongoing implementation of the Drug Quality and Security Act and to advance the goals of its 2018 Compounding Policy Priorities Plan, the US Food and Drug Administration is announcing several actions to protect public health related to the compounding of human drug products.

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.