Ergogenic aids

FDA Approves Supplemental New Drug Application for Adhansia XR® (methylphenidate HCl) Extended-Release Capsules CII

Retrieved on: 
Thursday, July 1, 2021
Biotechnology, FDA, Pharmaceutical, Health, Psychoactive drugs, Stimulants, Nootropics, Ergogenic aids, Euphoriants, Norepinephrine-dopamine reuptake inhibitors, Methylphenidate, Purdue Pharma, XR, Attention deficit hyperactivity disorder management

Adlon Therapeutics L.P., a subsidiary of Purdue Pharma L.P., announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to update the prescribing information for Adhansia XR (methylphenidate hydrochloride) extended-release capsules CII.

Key Points: 
  • Adlon Therapeutics L.P., a subsidiary of Purdue Pharma L.P., announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to update the prescribing information for Adhansia XR (methylphenidate hydrochloride) extended-release capsules CII.
  • Adhansia XR was approved by FDA for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients six years and older in February 2019.
  • Adhansia XR capsules contain identical beads which are formulated using the proprietary smart design MLR (Multi-Layer Release) technology.
  • Adhansia XR is contraindicated in patients with a known hypersensitivity to methylphenidate or other components of Adhansia XR.

KemPharm Announces Serdexmethylphenidate (SDX) Has Been Classified as a Schedule IV Controlled Substance by the DEA

Retrieved on: 
Friday, May 7, 2021
Psychoactive drugs, Stimulants, Nootropics, Norepinephrine-dopamine reuptake inhibitors, Euphoriants, Ergogenic aids, Controlled Substances Act, Methylphenidate, Pemoline, Dexmethylphenidate, Schedule 4, Schedule 2

AZSTARYS is classified as a Schedule II controlled substance as it includes a 70:30 mixture of SDX (Schedule IV) and d-MPH (Schedule II), respectively.\nAccording to the \xe2\x80\x9cSchedules of Controlled Substances: Placement of Serdexmethylphenidate in Schedule IV,\xe2\x80\x9d which has been published in the Federal Register (federalregister.gov/d/2021-09738), the DEA concluded that SDX meets the 21 U.S.C.

Key Points: 
  • AZSTARYS is classified as a Schedule II controlled substance as it includes a 70:30 mixture of SDX (Schedule IV) and d-MPH (Schedule II), respectively.\nAccording to the \xe2\x80\x9cSchedules of Controlled Substances: Placement of Serdexmethylphenidate in Schedule IV,\xe2\x80\x9d which has been published in the Federal Register (federalregister.gov/d/2021-09738), the DEA concluded that SDX meets the 21 U.S.C.
  • 812(b)(4) criteria for placement in schedule IV of the Controlled Substances Act (CSA).
  • \xe2\x80\x9cKP879, which is intended for the treatment of stimulant use disorder, is based on SDX as the sole API.
  • KemPharm\xe2\x80\x99s lead clinical development candidate for the treatment of SUD, KP879, is based on its prodrug of d-methylphenidate, known as serdexmethylphenidate (SDX).

Noven Submits New Drug Application for Investigational Dextroamphetamine Transdermal System for ADHD

Retrieved on: 
Monday, February 22, 2021
FDA, General Health, Pharmaceutical, Health, Psychoactive drugs, Drugs, Health sciences, Substituted amphetamines, Stimulants, Ergogenic aids, Phenethylamines, Transdermal patch, Hisamitsu Pharmaceutical, Amphetamine, New Drug Application, Food and Drug Administration

Noven Pharmaceuticals, Inc., (Noven) a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today confirmed it has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its dextroamphetamine transdermal system (ATS).

Key Points: 
  • Noven Pharmaceuticals, Inc., (Noven) a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today confirmed it has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its dextroamphetamine transdermal system (ATS).
  • Currently, there is no amphetamine-based transdermal treatment option available for ADHD.
  • The NDA submission is supported by results from a multicenter, laboratory classroom study which evaluated the safety and efficacy of ATS in over 100 pediatric patients with ADHD.
  • Novens mission is to develop and offer pharmaceutical products that meaningfully benefit patients around the world, with a commitment to advancing patient care through transdermal drug delivery.

4 Gauge Review: Explosive Pre-workout 4 Gauge Supplement By Roar Ambition

Retrieved on: 
Thursday, January 21, 2021
Ergogenic aids, Bodybuilding supplements, Health, Drugs, Dietary Supplements, Psychoactive drugs, Creatine, Guanidines, Caffeine, Bench, Fitness

Fitness experts recommend 4 Gauge to gym-users and weightlifters for muscle building, endurance, and more energy.

Key Points: 
  • Fitness experts recommend 4 Gauge to gym-users and weightlifters for muscle building, endurance, and more energy.
  • People who used a supplement could do additional minutes of intensive workout, including bench-presses, dead-lifts, squats, prone rows, and more.
  • MUST SEE: "Shocking New 4 Gauge Report This May Change Your Mind"
    Most weightlifters, both male, and female, use supplements that contain creatine and caffeine.
  • 4 Gauge is a natural, potent supplement, helping users exercise harder and giving them a boost in both physical and mental fitness.

4 Gauge Review: Explosive Pre-workout 4 Gauge Supplement By Roar Ambition

Retrieved on: 
Thursday, January 21, 2021
Ergogenic aids, Bodybuilding supplements, Health, Drugs, Dietary Supplements, Psychoactive drugs, Creatine, Guanidines, Caffeine, Bench, Fitness

Fitness experts recommend 4 Gauge to gym-users and weightlifters for muscle building, endurance, and more energy.

Key Points: 
  • Fitness experts recommend 4 Gauge to gym-users and weightlifters for muscle building, endurance, and more energy.
  • People who used a supplement could do additional minutes of intensive workout, including bench-presses, dead-lifts, squats, prone rows, and more.
  • MUST SEE: "Shocking New 4 Gauge Report This May Change Your Mind"
    Most weightlifters, both male, and female, use supplements that contain creatine and caffeine.
  • 4 Gauge is a natural, potent supplement, helping users exercise harder and giving them a boost in both physical and mental fitness.

Tris Pharma to Debut Amphetamine Extended-Release Tablet Efficacy and Safety Data at the 2021 APSARD Annual Meeting

Retrieved on: 
Friday, January 15, 2021
Drugs, Psychoactive drugs, Health sciences, Substituted amphetamines, Anorectics, Ergogenic aids, Phenethylamines, Stimulants, Amphetamine, Medication, Pharmaceutical industry, Attention deficit hyperactivity disorder management

The presentation, "Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study to Evaluate the Efficacy and Safety of the Amphetamine Extended-Release Tablet in Adults with Attention-Deficit/Hyperactivity Disorder," provides original data about the efficacy and safety of the new tablet formulation.

Key Points: 
  • The presentation, "Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study to Evaluate the Efficacy and Safety of the Amphetamine Extended-Release Tablet in Adults with Attention-Deficit/Hyperactivity Disorder," provides original data about the efficacy and safety of the new tablet formulation.
  • This presentation will be delivered during the Scientific Poster Session on Friday, January 15, 2021 from 6:007:30 PM EST.
  • This new amphetamine extended-release tablet is an investigational agent and is not currently approved for use in any country.
  • Tris Pharma is a New Jersey-based specialty pharmaceutical company focused on the development and commercialization of innovative medicines that address unmet patient needs.

Adlon Therapeutics L.P. Announces Two New Publications of Adhansia XR® (methylphenidate HCl) Extended-Release Capsules CII Data

Retrieved on: 
Wednesday, November 18, 2020
Biotechnology, Pharmaceutical, Health, Psychoactive drugs, Drugs, Psychoanaleptics, Stimulants, Phenethylamines, Euphoriants, Nootropics, Ergogenic aids, Methylphenidate, Amphetamine, Purdue Pharma, Boxed warning, Adhansia XR®, Adlon Therapeutics L.P.

Adlon Therapeutics L.P., a subsidiary of Purdue Pharma L.P., announced two recent online publications of studies related to the efficacy, safety and pharmacokinetics of Adhansia XR (methylphenidate hydrochloride) extended-release capsules CII (investigationally known as PRC-063).

Key Points: 
  • Adlon Therapeutics L.P., a subsidiary of Purdue Pharma L.P., announced two recent online publications of studies related to the efficacy, safety and pharmacokinetics of Adhansia XR (methylphenidate hydrochloride) extended-release capsules CII (investigationally known as PRC-063).
  • The Full Prescribing Information for Adhansia XR contains a Boxed Warning emphasizing that CNS stimulants, including Adhansia XR, other methylphenidate-containing products, and amphetamines have a high potential for abuse and dependence.
  • Adhansia XR is not appropriate for all patients, and healthcare professionals should work with their patients to determine the most appropriate treatment option.
  • Adhansia XR is contraindicated in patients with a known hypersensitivity to methylphenidate or other components of Adhansia XR.

Tris Pharma to Present Amphetamine Extended-Release Tablet Data at the Research Pipeline Session of 2020 American Academy of Child and Adolescent Psychiatry Meeting

Retrieved on: 
Thursday, October 22, 2020
Drugs, Health, Dosage forms, Pharmaceutical industry, Substituted amphetamines, Ergogenic aids, TAAR1 agonists, Medication, Amphetamine, Tablet, Formulation

The presentation, "Palatability Assessment of a New Amphetamine Extended-Release Chewable Tablet Formulation" provides original data about the acceptability, mouthfeel, and taste of the new formulation.

Key Points: 
  • The presentation, "Palatability Assessment of a New Amphetamine Extended-Release Chewable Tablet Formulation" provides original data about the acceptability, mouthfeel, and taste of the new formulation.
  • This presentation will be delivered during the session "Research Pipeline: New Findings on Diagnostics and Therapeutics" on Friday, October 23, 2020 from 2pm 4pm (EDT) and chaired by Timothy Wilens, MD.
  • This new amphetamine extended-release tablet is an investigational agent and is not currently approved for use in any country.
  • Tris Pharma is a New Jersey-based specialty pharmaceutical company focused on the development and commercialization of innovative medicines that address unmet patient needs.

Dr. Reddy's Laboratories announces the launch of Amphetamine Sulfate Tablets USP, in the U.S. Market

Retrieved on: 
Tuesday, April 14, 2020
General Health, Health, Science, Pharmaceutical, Research, Psychoactive drugs, Drugs, Substituted amphetamines, Stimulants, Ergogenic aids, Euphoriants, Phenethylamines, Amphetamine, Dr. Reddy's Laboratories, Generic drug

Dr. Reddys Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as Dr. Reddys) today announced the launch of Amphetamine Sulfate Tablets USP, a therapeutic equivalent generic version of Evekeo (amphetamine sulfate) Tablets approved by the U.S. Food and Drug Administration (USFDA).

Key Points: 
  • Dr. Reddys Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as Dr. Reddys) today announced the launch of Amphetamine Sulfate Tablets USP, a therapeutic equivalent generic version of Evekeo (amphetamine sulfate) Tablets approved by the U.S. Food and Drug Administration (USFDA).
  • Amphetamine Sulfate Tablets, USP is a Schedule II drug.
  • The Evekeo brand and generic had U.S. sales of approximately $38 million MAT for the most recent twelve months ending in January 2020 according to IQVIA Health*.
  • Dr. Reddys Amphetamine Sulfate Tablets USP are available in 5 mg and 10 mg dose in bottle count sizes of 100.

Quillivant XR®, QuilliChew ER® and Dyanavel® XR are 100% Made in the U.S.A. and Remain Consistently Supplied During COVID-19 Pandemic

Retrieved on: 
Tuesday, March 17, 2020
Psychoactive drugs, Drugs, Stimulants, Nootropics, Ergogenic aids, Phenethylamines, Euphoriants, Methylphenidate, Amphetamine, Ford Falcon, Attention deficit hyperactivity disorder, XR, Psychoactive drugs, Drugs, Stimulants, Nootropics, Ergogenic aids, Phenethylamines, Euphoriants, Methylphenidate, Amphetamine, Ford Falcon, Attention deficit hyperactivity disorder, XR

Quillivant XR, QuilliChew ER, and Dyanavel XR are approved for treatment of ADHD in people 6 years and older.

Key Points: 
  • Quillivant XR, QuilliChew ER, and Dyanavel XR are approved for treatment of ADHD in people 6 years and older.
  • It is not known if Dyanavel XR, Quillivant XR, and QuilliChew ER are safe and effective in children under 6 years of age.
  • Dyanavel XR, Quillivant XR, and QuilliChew ERare federally controlled substances (CII) because they can be abused or lead to dependence.
  • Call the doctor right away if any signs of unexplained wounds appear on fingers or toes while taking Dyanavel XR, Quillivant XR, or QuilliChew ER.