Antidepressants

Ketamine Infusion Therapy Now Available in Carlsbad New Mexico

Retrieved on: 
Friday, September 14, 2018

CARLSBAD, N.M., Sept. 14, 2018 /PRNewswire-PRWeb/ --One of the country's most respected ketamine infusion providers, has just opened a new center in Carlsbad, New Mexico.

Key Points: 
  • CARLSBAD, N.M., Sept. 14, 2018 /PRNewswire-PRWeb/ --One of the country's most respected ketamine infusion providers, has just opened a new center in Carlsbad, New Mexico.
  • Klarisana, which is well known to residents of central Texas with its established ketamine infusion centers in Austin and San Antonio, has now crossed its western border to offer ketamine therapy to patients in southeast New Mexico.
  • Klarisana's Clinical Director in Carlsbad is Shannon Roper, a lifelong resident of Carlsbad and an experienced Family Nurse Practitioner.
  • Patients and clinicians in the Carlsbad and Roswell, New Mexico area who want to learn more about Klarisana and what ketamine infusion therapy can do, are encouraged to visit Klarisana's website at Klarisana.com or call the main number at 210-556-1430.

Teva Canada Announces the Launch of a Generic Version of (PR)Abilify®, (PR)Teva-Aripiprazole Tablets for the treatment of Schizophrenia

Retrieved on: 
Monday, September 10, 2018

The launch of PrTeva-Aripiprazole provides patients with an affordable, bioequivalent alternative to PrAbilify and demonstrates our ongoing commitment to improving people's lives."

Key Points: 
  • The launch of PrTeva-Aripiprazole provides patients with an affordable, bioequivalent alternative to PrAbilify and demonstrates our ongoing commitment to improving people's lives."
  • Aripiprazole tablets (brand: PrAbilify) had annual sales of approximately $182 million in Canada, based on IQVIA sales data as of July 2018.
  • Teva Canada employs more than 1,000 professionals, markets more than 400productsv in 1,700 SKUs in Canada and is a subsidiary of Teva Pharmaceutical Industries Ltd., the world's largest generic drug maker.
  • https://www.psychiatry.org/patients-families/schizophrenia/what-is-schiz... | Canadian Mental Health Association - Mental Health - Understanding Mental Illness - Schizophrenia https://cmha.ca/mental-health/understanding-mental-illness/schizophrenia | World Health Organization - What is schizophrenia?

Janssen Submits Esketamine Nasal Spray New Drug Application to U.S. FDA for Treatment-Resistant Depression

Retrieved on: 
Tuesday, September 4, 2018

TITUSVILLE, N.J., Sept. 4, 2018 /PRNewswire/ --The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for esketamine nasal spray.

Key Points: 
  • TITUSVILLE, N.J., Sept. 4, 2018 /PRNewswire/ --The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for esketamine nasal spray.
  • Esketamine nasal spray will be self-administered by patients under the supervision of health care professionals.
  • Janssen plans to submit a Marketing Authorization Application (MAA)to the European Medicines Agency (EMA) for the esketamine treatment-resistant depression indication later in 2018.
  • A Randomized Withdrawal, Double-blind, Multicenter Study of Esketamine Nasal Spray Plus an Oral Antidepressant for Relapse Prevention in Treatment-resistant Depression.

Kindred Biosciences to Participate in the CL King 16th Annual Best Ideas Conference, Lake Street Capital Markets 2nd Annual Best Ideas Growth Conference and LD Micro San Francisco Summit

Retrieved on: 
Thursday, August 30, 2018

SAN FRANCISCO, Aug. 30, 2018 /PRNewswire/ -- Kindred Biosciences, Inc.(NASDAQ: KIN), a commercial-stage biopharmaceutical company focused on saving and improving the lives of pets, will participate in the LD Micro San Francisco Summit taking place September 4th, the CL King 16th Annual Best Ideas Conference and the Lake Street Capital Markets 2nd Annual Best Ideas Growth Conference, both taking place September 13th in New York.

Key Points: 
  • SAN FRANCISCO, Aug. 30, 2018 /PRNewswire/ -- Kindred Biosciences, Inc.(NASDAQ: KIN), a commercial-stage biopharmaceutical company focused on saving and improving the lives of pets, will participate in the LD Micro San Francisco Summit taking place September 4th, the CL King 16th Annual Best Ideas Conference and the Lake Street Capital Markets 2nd Annual Best Ideas Growth Conference, both taking place September 13th in New York.
  • Mirataz (mirtazapine transdermal ointment) is for topical use in cats only under veterinary supervision.
  • Do not use in cats with a known hypersensitivity to mirtazapine or any of the excipients or in cats treated with monoamine oxidase inhibitors (MAOIs).
  • Its mission is to bring to pets the same kinds of safe and effective medicines that human family members enjoy.

FDA Should Take A Fresh Look At Kratom Science

Retrieved on: 
Tuesday, August 21, 2018

In an online press conference today , Dr. Jane Babinauthor of a recent white paper disclosing numerous errors, omission, and misstatements committed by the FDA in analyzing deaths it erroneously associates with kratomcalled upon FDA to "take a fresh look as scientists."

Key Points: 
  • In an online press conference today , Dr. Jane Babinauthor of a recent white paper disclosing numerous errors, omission, and misstatements committed by the FDA in analyzing deaths it erroneously associates with kratomcalled upon FDA to "take a fresh look as scientists."
  • Those who use kratom are not inclined to use more, and research demonstrates that "those who have been using drugs before kratom seek out kratom to mitigate their dependence on drugs."
  • According to Dr. Grundmann, "Kratom is used as a harm reduction agentan important step that speaks against (the FDA's claim) that kratom is a gateway drug."
  • AKA released its recommendations for good manufacturing practices (GMP) for kratom, which includes maintaining purity from contaminating substances.

AKA Announces GMP Standards To Protect Consumers From Adulterated Kratom Products

Retrieved on: 
Tuesday, August 21, 2018

WASHINGTON, Aug. 21, 2018 /PRNewswire/ -- The American Kratom Association (AKA) published its "Good Manufacturing Practice (GMP) Standards for the Manufacture of Kratom Products" to provide specific guidance to kratom manufacturers and vendors in the manufacturing and marketing of kratom products.

Key Points: 
  • WASHINGTON, Aug. 21, 2018 /PRNewswire/ -- The American Kratom Association (AKA) published its "Good Manufacturing Practice (GMP) Standards for the Manufacture of Kratom Products" to provide specific guidance to kratom manufacturers and vendors in the manufacturing and marketing of kratom products.
  • Dave Herman, Chairman of the AKA, affirmed the commitment of the AKA to establish a supply chain of safe kratom products.
  • "We want consumers to have access to a list of manufacturers and vendors who have agreed to adhere to FDA good manufacturing standards, and to a higher set of standards AKA is requesting to protect those consumers."
  • Qualified vendors will then be added to the list of AKA vendors that will be available to kratom consumers.

American Kratom Association Accuses FDA Of Manipulating, Obscuring, And Ignoring Science

Retrieved on: 
Tuesday, August 14, 2018

That report concluded the deaths were actually the result of adulteration of kratom powder with a toxic dose of O-desmethyltramadol.

Key Points: 
  • That report concluded the deaths were actually the result of adulteration of kratom powder with a toxic dose of O-desmethyltramadol.
  • Two deaths claimed in the documents released by the FDA are the same death reported twice (FAERS ID No.
  • In most cases, the cumulative contributions of multiple drugs and interactions between drugs are not even considered by FDA.
  • The American Kratom Association (AKA), a consumer-based non-profit organization, focuses on setting the record straight about kratom and gives a voice to those who are suffering by protecting their rights to possess and consume safe and natural kratom.

Safety Of Unadulterated Kratom Affirmed By The National Institute Of Drug Abuse

Retrieved on: 
Monday, July 30, 2018

"NIDA's position does not come as a surprise," said Dave Herman, Chairman of the American Kratom Association (AKA), which is committed to protecting the rights of consumers who use kratom safely and successfully.

Key Points: 
  • "NIDA's position does not come as a surprise," said Dave Herman, Chairman of the American Kratom Association (AKA), which is committed to protecting the rights of consumers who use kratom safely and successfully.
  • The FDA and NIDA have a long-standing formal agreement that both agencies must concur on scheduling recommendations submitted to the DEA.
  • "In fact, it could be applied to anything, even broccoli, once it has been contaminated with a dangerous substance."
  • The American Kratom Association (AKA), a consumer-based non-profit organization, focuses on setting the record straight about kratom and gives a voice to those who are suffering by protecting their rights to possess and consume safe and natural kratom.

Allergan Receives FDA Fast Track Designation for AGN-241751 for the Treatment of Major Depressive Disorder (MDD)

Retrieved on: 
Monday, July 23, 2018

DUBLIN, July 23, 2018 /PRNewswire/ --Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration has granted Fast Track designation for AGN-241751, an investigational new treatment for Major Depressive Disorder (MDD).

Key Points: 
  • DUBLIN, July 23, 2018 /PRNewswire/ --Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration has granted Fast Track designation for AGN-241751, an investigational new treatment for Major Depressive Disorder (MDD).
  • The Fast Track designation will allow Allergan to work more closely with the FDA to bring AGN-241751 to patients as soon as possible."
  • Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
  • Allergan acquired AGN-241751 as part of its ongoing research effort with Aptinyx, Inc.
    AGN-241751 development follows Rapastinel, which received FDA Fast Track Designation in 2014 and Breakthrough Designation from the FDA in 2016.

Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner for Foods and Veterinary Medicine Steven Ostroff, M.D., on the ongoing risk of salmonella in kratom products

Retrieved on: 
Monday, July 2, 2018

The FDA has now concluded its months-long investigation after identifying extremely high rates of salmonella contamination in kratom products collected and tested.

Key Points: 
  • The FDA has now concluded its months-long investigation after identifying extremely high rates of salmonella contamination in kratom products collected and tested.
  • The collected kratom samples were tested for the presence of salmonella either in state public health laboratories or by FDA laboratories.
  • If salmonella was found, the FDA worked with marketers to voluntarily recall the kratom product to prevent additional people from becoming ill.
  • In addition to SalmonellaI4,[5],12:b:-, illnesses have been linked to Salmonella Heidelberg, Salmonella Javiana, Salmonella Okatie, Salmonella Thompson and Salmonella Weltevreden.