Ketones

Amneal Announces the Approval and Launch of Generic Isoproterenol Hydrochloride Injection USP

Retrieved on: 
Friday, October 19, 2018
Neurochemistry, Chemistry, Cell signaling, Ketones, Euphoriants, Chloroarenes, Analgesics, RTT, Amneal Pharmaceuticals, Ketamine

BRIDGEWATER, N.J., Oct. 19, 2018 /PRNewswire/ --Amneal Pharmaceuticals, Inc. (NYSE: AMRX), today announced that it has received FDA approval for a generic version of IsuprelTM Injection (isoproterenol hydrochloride) USP, 0.2 mg/mL and 1 mg/5 mL(0.2 mg/mL) Single-Dose Vials.

Key Points: 
  • BRIDGEWATER, N.J., Oct. 19, 2018 /PRNewswire/ --Amneal Pharmaceuticals, Inc. (NYSE: AMRX), today announced that it has received FDA approval for a generic version of IsuprelTM Injection (isoproterenol hydrochloride) USP, 0.2 mg/mL and 1 mg/5 mL(0.2 mg/mL) Single-Dose Vials.
  • "We are pleased to add Isoproterenol to our portfolio of injectable products," said Andy Boyer, Executive Vice President of Commercial Operations for Amneal.
  • According to IQVIA, U.S market annual sales for the 12 months ended August 2018 for Isoproterenol Hydrochloride Injection USP, 0.2 mg/mL and 1 mg/5 mL(0.2 mg/mL) Single-Dose Vials is estimated to be approximately $158 million.
  • Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is an integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products.

Perrigo Announces The Launch Of An AB Rated Generic Version Of Androgel® Topical Gel, 1.62%

Retrieved on: 
Monday, October 15, 2018
Chemistry, Medicine, Endocrine system, Ketones, Alcohols, Androstanes, GABAA receptor positive allosteric modulators, Estrogens, Testosterone, Perrigo, Topical medication

At generic market formation, an unrelated third party has launched an authorized generic version.

Key Points: 
  • At generic market formation, an unrelated third party has launched an authorized generic version.
  • Androgel Topical Gel, 1.62% is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.
  • Annual market sales for Androgel Topical Gel, 1.62% for the 12 months ending August 2018 were approximately $1 billion as measured by IQVIA.
  • Perrigo Executive Vice President and President Rx Pharmaceuticals John Wesolowski stated, "This launch exemplifies Perrigo's ongoing commitment to developing quality, high value alternatives in important treatment categories.

U.S. FDA Announces Joint Advisory Committee Review of Mallinckrodt's Abuse-Deterrent, Immediate-Release Reformulation of Roxicodone® (Oxycodone Hydrochloride)

Retrieved on: 
Monday, October 8, 2018
Neurochemistry, Health, Pharmacology, Euphoriants, Pharmaceuticals policy, Morphinans, Ketones, RTT, Oxycodone, Mallinckrodt, Prescription Drug User Fee Act, Food and Drug Administration

Mallinckrodt is advancing this reformulation of Roxicodone (oxycodone hydrochloride tablets USP) with properties designed to deter intravenous and intranasal abuse.

Key Points: 
  • Mallinckrodt is advancing this reformulation of Roxicodone (oxycodone hydrochloride tablets USP) with properties designed to deter intravenous and intranasal abuse.
  • The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 16, 2018, to complete its review of Mallinckrodt's product.
  • Therefore, investors should look to the Investor Relations page of the website for important and time-critical information.
  • This release includes forward-looking statements concerning MNK-812 including expectations with regard to future regulatory actions and potential impact on patients.

Relmada Therapeutics to Present Clinical Data on the Effect of REL-1017 on BDNF Plasma Levels

Retrieved on: 
Tuesday, October 2, 2018
Neurochemistry, Chemistry, Cell signaling, Antidepressants, Amines, Ketones, Euphoriants, RTT, Ketamine, Methadone

The study will enroll 60 subjects at approximately 10 sites in the United States.

Key Points: 
  • The study will enroll 60 subjects at approximately 10 sites in the United States.
  • In preclinical studies, REL-1017 showed antidepressant efficacy and effects on neuronal activity similar to that of ketamine.
  • The U.S. Food and Drug Administration previously granted Fast Track designation for dextromethadone for the adjunctive treatment of MDD.
  • Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

FAIR Health Releases State-by-State Visualizations of Opioid Abuse and Dependence

Retrieved on: 
Monday, October 1, 2018
RTT, Chemistry, Organic chemistry, Ketones, Drug rehabilitation, Morphinans, Substance dependence, Naltrexone, Opioid use disorder, Methadone, Opioid

The infographic includes the top five procedures associated with opioid abuse and dependence by utilization and aggregate cost, such as methadone administration, naltrexone injection and group psychotherapy.

Key Points: 
  • The infographic includes the top five procedures associated with opioid abuse and dependence by utilization and aggregate cost, such as methadone administration, naltrexone injection and group psychotherapy.
  • Each infographic also shows the percentages of opioid abuse and dependence diagnoses by age group and gender in the state.
  • FAIR Health President Robin Gelburd stated: "Our interactive heat map on opioid abuse and dependence opens a new geographic window into this serious epidemic.
  • FAIR Health stands ready to assist healthcare stakeholders with similar analytics and visualizations for other pressing public health concerns."

Sandoz Inc. announces US FDA approval of pediatric dose of SYMJEPI™ (epinephrine)

Retrieved on: 
Thursday, September 27, 2018
Chemistry, Medicine, RTT, Health, Alcohols, Epinephrine, Respiratory therapy, Lactams, Ketones, Pharmaceutical industry, Lorazepam, Conjugated estrogens

Sandoz will distribute and commercialize SYMJEPI (epinephrine) 0.15 mg Injection, as well as SYMJEPI 0.3 mg Injection, in the US under an exclusive agreement with Adamis Pharmaceuticals Corporation.

Key Points: 
  • Sandoz will distribute and commercialize SYMJEPI (epinephrine) 0.15 mg Injection, as well as SYMJEPI 0.3 mg Injection, in the US under an exclusive agreement with Adamis Pharmaceuticals Corporation.
  • You are encouraged to report negative side effects of prescription drugs to FDA.
  • This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995.
  • Neither can there be any guarantee that SYMJEPI will be commercially successful in the future.

Lipocine to Present at the Ladenburg Thalmann 2018 Healthcare Conference

Retrieved on: 
Tuesday, September 25, 2018
Chemistry, Androstanes, Ketones, Alcohols, Medicine, Organic chemistry, Testosterone undecanoate, Testosterone, Hypogonadism, Testosterone buciclate, EC586

Lipocine Inc. is a specialty pharmaceutical company developing innovative pharmaceutical products for use in men's and women's health using its proprietary drug delivery technologies.

Key Points: 
  • Lipocine Inc. is a specialty pharmaceutical company developing innovative pharmaceutical products for use in men's and women's health using its proprietary drug delivery technologies.
  • Lipocine's clinical development pipeline includes four development programs TLANDO, LPCN 1111, LPCN 1107 and LPCN 1144.
  • TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men.
  • LPCN 1144, an oral androgen, is being developed as a treatment of non-alcoholic steatohepatitis ("NASH") and is currently being studied in two proof-of-concept clinical studies.

Low T Center Expands Services to Help Men with their Overall Health & Wellness

Retrieved on: 
Monday, September 17, 2018
Endocrine system, Chemistry, Medicine, Alcohols, Alkenes, Androstanes, Estrogens, Ketones, Hypogonadism, Testosterone

Low T Center will continue to embrace a patient-focused model, where customer service and patient experience are prioritized.

Key Points: 
  • Low T Center will continue to embrace a patient-focused model, where customer service and patient experience are prioritized.
  • "Historically, men don't like going to the doctor and many men don't go to the doctor even when they don't feel well.
  • And for the thousands of men with symptoms that have come to Low T over the years but didn't have low testosterone, now we can help," said Mike Sisk, Founder of Low T Center.
  • In 2018, Low T Center expanded services to provide a holistic approach to men's health.

Salix Pharmaceuticals To Present Clinical Data For The Treatment Of Opioid-Induced Constipation At 2018 PAINWeek Conference

Retrieved on: 
Friday, September 7, 2018
Chemistry, Morphinans, Organic chemistry, RTT, Opioid antagonists, Ketones, Phenols, Methylnaltrexone, Opioid, Naltrexone, Constipation, Heroin

The complete schedule of research that will be presented on methylnaltrexone data at PAINWeek on September 6 includes:

Key Points: 
  • The complete schedule of research that will be presented on methylnaltrexone data at PAINWeek on September 6 includes:
    Bruce Chamberlain, MD.
  • "Methylnaltrexone for the Relief of Constipation due to Chronic Opioid Therapy in Advanced Illness Patients With and Without Active Cancer."
  • RELISTOR (methylnaltrexone bromide) is a prescription medicine used to treat constipation in adults that is caused by prescription pain medicines called opioids.
  • Salix is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases.

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

Retrieved on: 
Tuesday, September 4, 2018
Neurochemistry, Chemistry, Pharmacology, NMDA receptor antagonists, Antidepressants, Nicotinic antagonists, Amines, Ketones, Esketamine, Ketamine, Major depressive disorder, Janssen Pharmaceutica

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.