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Alfasigma
Alfasigma USA, Inc. (''formerly'' Pamlab) is an American medical food company, and a division of Alfasigma Group, of Bologna, Italy. Alfasigma's base of operations is located in Bedminster, New Jersey. History The company entered the pharmaceutical industry in 1957, initially introducing prescription cough/cold products. In 1987, Pamlab was purchased by Samuel and Judith Camp. In early 2013, Pamlab was purchased by Nestlé Health Science. In December 2016, Pamlab was purchased by Alfasigma Group of Bologna, Italy. Legal actions Alfasigma USA, Inc. was sued by ExeGi Pharma LLC and the Italian inventor of probiotic VSL#3, Claudio De Simone, for making false advertising claims and ownership rights to VSL#3. According to court documents: "Defendant VSL Inc., and its licensees Alfasigma and Leadiant, having lost the right to sell the De Simone Formulation, decided to manufacture, market, and sell a different, inferior formulation (the “Fraudulent Formulation”) without cond ...
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VSL(3)
The De Simone Formulation is a probiotic formula and manufacturing method developed by Claudio De Simone. The De Simone Formulation has been clinically studied for a variety of health conditions since the 1990s but it has been researched the most for its efficacy in the medical management of chronic intestinal conditions including irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD). Lawsuits The De Simone Formulation has been the subject of lawsuits. In the United States, the 4th U.S. Circuit Court of Appeals upheld a false advertising verdict against the makers of the VSL#3 probiotic in February 2021 stating there was enough evidence to support a jury's November 2018 finding that the makers of VSL#3 had quote "reverse-engineered an imperfect copy" of De Simone's signature probiotic formulation that was sold under the brand name VSL#3 through May 2016 after he withdrew from their joint venture, VSL Pharmaceuticals Inc. According to the lawsuit, his departure wa ...
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Cerefolin NAC
Cerefolin is a prescription medication made by Pamlab that contains 5.635 mg of folate as L-methylfolate, 1 mg of vitamin B12 as methylcobalamin, 50 mg of vitamin B2 as riboflavin, and 5 mg of vitamin B6 as pyridoxine. It is approved by the U.S. Food and Drug Administration for the treatment or prevention of vitamin deficiencies Vitamin deficiency is the condition of a long-term lack of a vitamin. When caused by not enough vitamin intake it is classified as a ''primary deficiency'', whereas when due to an underlying disorder such as malabsorption it is called a ''seconda .... "Cerefolin NAC" contains L-methylfolate (as Metafolin) 5.6 mg, methylcobalamin 2 mg, N-acetylcysteine 600 mg. Risks Cerefolin is a potentially harmful drug. Adverse effects can include diarrhea, Hand-foot syndrome, Rashes, Renal stones, Constipation, headaches, flushing, and swelling. References Vitamins Combination drugs {{gastrointestinal-drug-stub ...
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Metanx
Metanx is a prescription medical food made by Alfasigma that contains L-methylfolate (as Metafolin, a calcium salt of vitamin B9), methylcobalamin (vitamin B12) and pyridoxal 5'-phosphate (vitamin B6). It is a vitamin B supplement. Metanx is indicated for the dietary management of peripheral neuropathy (i.e. DPN). Ingredients Metanx contains the following active ingredients (per capsule): * Folate * L-methylfolate (Metafolin): 3 mg * Pyridoxal 5'-phosphate: 35 mg * Methylcobalamin: 2 mg (Google Books) Indication and usage Metanx is used for treating: * Painful diabetic neuropathy, (Google Books) * Diabetic foot ulcers, * Endothelial dysfunction associated with diabetic peripheral neuropathy, * Hyperhomocysteinemia Hyperhomocysteinemia is a medical condition characterized by an abnormally high level of total homocysteine (that is, including homocystine and homocysteine-cysteine disulfide) in the blood, conventionally described as above 15 μmol/L. As .... Refe ...
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Medical And Health Organizations Based In Louisiana
Medicine is the science and practice of caring for patients, managing the diagnosis, prognosis, prevention, treatment, palliation of their injury or disease, and promoting their health. Medicine encompasses a variety of health care practices evolved to maintain and restore health by the prevention and treatment of illness. Contemporary medicine applies biomedical sciences, biomedical research, genetics, and medical technology to diagnose, treat, and prevent injury and disease, typically through pharmaceuticals or surgery, but also through therapies as diverse as psychotherapy, external splints and traction, medical devices, biologics, and ionizing radiation, amongst others. Medicine has been practiced since prehistoric times, and for most of this time it was an art (an area of creativity and skill), frequently having connections to the religious and philosophical beliefs of local culture. For example, a medicine man would apply herbs and say prayers for healing, or an ancie ...
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Food Manufacturers Of The United States
Food is any substance consumed by an organism for nutritional support. Food is usually of plant, animal, or fungal origin and contains essential nutrients such as carbohydrates, fats, proteins, vitamins, or minerals. The substance is ingested by an organism and assimilated by the organism's cells to provide energy, maintain life, or stimulate growth. Different species of animals have different feeding behaviours that satisfy the needs of their metabolisms and have evolved to fill a specific ecological niche within specific geographical contexts. Omnivorous humans are highly adaptable and have adapted to obtaining food in many different ecosystems. Humans generally use cooking to prepare food for consumption. The majority of the food energy required is supplied by the industrial food industry, which produces food through intensive agriculture and distributes it through complex food processing and food distribution systems. This system of conventional agriculture r ...
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Nestlé Brands
Nestlé S.A. ( ) is a Swiss multinational food and drink processing conglomerate corporation headquartered in Vevey, Switzerland. It has been the largest publicly held food company in the world, measured by revenue and other metrics, since 2014."Nestlé's Brabeck: We have a 'huge advantage' over big pharma in creating medical foods"
, CNN Money, 1 April 2011
It ranked No. 64 on the ''Fortune'' Global 500 in 2017. In 2023, the company was ranked 50th in the ''Forbes'' Global 2000. Nestlé's products inc ...
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Medical Food
Medical food is food that is specially formulated and intended for the dietary management of a disease that has distinctive nutritional needs that cannot be met by normal diet alone. In the United States, it was defined in the Food and Drug Administration's 1988 Orphan Drug Act Amendments and subject to the general food and safety labeling requirements of the Federal Food, Drug, and Cosmetic Act. In Europe, the European Food Safety Authority established definitions for "foods for special medical purposes" (FSMPs) in 2015. Definition Medical foods, called "food for special medical purposes" in Europe, are distinct from the broader category of foods for special dietary use, from traditional foods that bear a health claim, and from dietary supplements. In order to be considered a medical food the product must, at a minimum: * be a food for oral ingestion or tube feeding ( nasogastric tube) * be labeled for the dietary management of a specific medical disorder, disease or condition fo ...
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Deplin
Levomefolic acid (INN, also known as L-5-MTHF, L-methylfolate and L-5-methyltetrahydrofolate and (6''S'')-5-methyltetrahydrofolate, and (6''S'')-5-MTHF) is the primary biologically active form of folate used at the cellular level for DNA reproduction, the cysteine cycle and the regulation of homocysteine. It is also the form found in circulation and transported across membranes into tissues and across the blood–brain barrier. In the cell, L-methylfolate is used in the methylation of homocysteine to form methionine and tetrahydrofolate (THF). THF is the immediate acceptor of one carbon unit for the synthesis of thymidine-DNA, purines (RNA and DNA) and methionine. The un-methylated form, folic acid (vitamin B9), is a synthetic form of folate, and must undergo enzymatic reduction by dihydrofolate reductase (DHFR) to become biologically active. Systematic reviews suggest that adjunctive L-methylfolate modestly improves symptoms in major depressive disorder. It is synthesized in the ...
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Major Depressive Disorder
Major depressive disorder (MDD), also known as clinical depression, is a mental disorder characterized by at least two weeks of pervasive depression (mood), low mood, low self-esteem, and anhedonia, loss of interest or pleasure in normally enjoyable activities. Introduced by a group of US clinicians in the mid-1970s, the term was adopted by the American Psychiatric Association for this syndrome, symptom cluster under mood disorders in the 1980 version of the ''Diagnostic and Statistical Manual of Mental Disorders'' (DSM-III), and has become widely used since. The disorder causes the second-most years lived with disability, after low back pain, lower back pain. The diagnosis of major depressive disorder is based on the person's reported experiences, behavior reported by family or friends, and a mental status examination. There is no laboratory test for the disorder, but testing may be done to rule out physical conditions that can cause similar symptoms. The most common time o ...
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