To treat adults with complicated urinary tract infections To treat children ages 2 to 12 years old with Chagas disease To treat adults with relapsed follicular lymphoma To treat certain advanced or metastatic breast cancers To treat adults with mantle cell lymphoma To treat intraocular pressure in patients with open-angle glaucoma or ocular hypertension. To prevent infection after bone marrow transplant To treat pediatric and adult patients with an inherited metabolic condition called mucopolysaccharidosis type VII (MPS VII), also known as Sly syndrome.ДЇor add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype To prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors. To improve glycemic control in adults with type 2 diabetes mellitus To increase blood pressure in adults with septic or other distributive shockДЇor the diagnosis of adult growth hormone deficiency FDAвЂ™s classification of a drug as an вЂњNMEвЂќ for review purposes is distinct from FDAвЂ™s determination of whether a drug product is a вЂњnew chemical entityвЂќ or вЂњNCEвЂќ within the meaning of the Federal Food, Drug, and Cosmetic Act.

For example, CDER classifies biological products submitted in an application under section 351(a) of the Public Health Service Act as NMEs for purposes of FDA review, regardless of whether the Agency previously has approved a related active moiety in a different product. Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that have previously been approved by FDA. Many of these products contain active moieties that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product these products frequently provide important new therapies for patients. Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace.Д¬ertain drugs are classified as new molecular entities (вЂњNMEsвЂќ) for purposes of FDA review.This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products approved in 2017 by the Center for Biologics Evaluation and Research. Some of these products are innovative new products that neverВ have been used in clinical practice.Below is a listing of new molecular entities and new therapeutic biological products approved by CDER in 2017.

For this reason, CDER supports innovation and plays a key role in helping to advance new drug development.Д®ach year, CDER approves a wide range of new drugs and biological products: The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public. With its understanding of the science used to create new products, testing and manufacturing procedures, and the diseases and conditions that new products are designed to treat, CDER provides scientific and regulatory advice needed to bring new therapies to market. When it comes to innovation in the development of new drugs and therapeutic biological products, FDAвЂ™s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process. As a result of improved forecasting and early warning systems, the death toll has dropped.Innovation drives progress. In the United States, there are two regions with a disproportionately high frequency of tornadoes. Historical records and trends for tornadoes, including graphs and maps showing timing and occurrences over approximately 60 years.

A storm with a tornado observed by radar has certain distinguishing features and forecasters are trained to recognize them.ДЄ summary of recentВ tornadic activity in the contiguous United States, including monthly tornado counts and descriptions of significant events. Additionally, computer programs, called algorithms, analyzeВ Doppler radarВ data and display it in ways that make it easier for forecasters to identify dangerous weather. Storm spotters can be emergency managers or even local people with a keen interest in severe weather who have taken formal storm spotter training in their community. Storm spottersВ have been trained to recognize tornado conditions and report what they see to the National Weather Service. Official counts of tornadoes come from NOAA's National Severe Storms Laboratory.

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