presentation template for kidney

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Nephrology kidney PowerPoint Presentation Template With Editable Charts

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Kidney Physiology PPT Presentation Template & Google Slides

Creative Kidney Physiology Template For Presentation

About this template , feature of this template .

• Kidney Physiology
• Kidney Dialysis
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Make your next PowerPoint, Google Slides, or Keynote presentation more effective with our professionally designed Kidney template. Improve the way you present seminars, webinars and lectures. Make more exciting sales presentations, trade show displays and product promotions, or use them in any educational setting for more impact and greater retention.

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Kidneys PowerPoint Templates

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Date Created: July 11, 2016 Last Updated: July 11, 2016

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RIGImmune Announces Multiple Oral Presentations for Intranasal RIG-101 at European Respiratory Society Congress 2024

• Pre-clinical studies for intranasal RIG-101, a first in class RIG-I agonist, demonstrate potent local innate immune stimulation and pan-viral activity against human rhinovirus, influenza and RSV infections.
• RIG-101 is in development for the pan-viral prevention of RNA virus transmission in asthma patients to inhibit seasonal exacerbations.
• RIG-101 intranasal (IN) is on track to enter first in human trials in mid-2025.

FARMINGTON, Conn., Sept. 09, 2024 (GLOBE NEWSWIRE) -- RIGImmune Inc., a biopharmaceutical research company developing a new class of RNA therapeutics, today announced three oral presentations demonstrating the viral prevention effects of intranasal RIG-101, their lead product development candidate, at the European Respiratory Society (ERS) Congress 2024 in Vienna, Austria. The three oral presentations highlight the impressive results from pre-clinical studies demonstrating that the company’s first in class RIG-I agonist has the ability to rapidly and substantially reduce viral loads by inducing innate immune responses when delivered directly to the respiratory tract. Intranasal RIG-101 is formulated with the company’s novel NEED™ (Nano-Emulsion Enhanced Delivery) platform, a complex designed to deliver a wide range of RNA payloads without the use of lipid nanoparticle encapsulation. The results from these studies and other company experiments demonstrate the potential for RIG-101 to inhibit the transmission of an RNA virus from an infected person to a non-infected individual and could significantly reduce viral infection-related respiratory complications in at-risk patient populations, including the immune-compromised and those with chronic respiratory diseases such as asthma and COPD.

“While the nose is an obvious passageway to leverage for infectious disease prevention, inefficient uptake of previous intranasal RNA therapeutics by the nasal epithelial cells has been a barrier to infection prevention,” said the senior author of all three studies, Kazuhiro Ito, Ph.D., principal research fellow of Respiratory Molecular Pharmacology in Genomic and Environmental Medicine Section in National Heart and Lung Institute (NHLI) in the Faculty of Medicine of Imperial College London, and vice president of biology at RIGImmune. “Our study results show that RIG-101, formulated with our proprietary NEED™ technology can induce efficient uptake into the epithelium and is uniquely optimized to activate the innate immune system to fight viral respiratory diseases with local intranasal administration. The NEED™ platform allows us to effectively deliver RNA therapeutic payloads directly to the upper and lower respiratory tract and avoid the use of LNPs, which can damage the respiratory system when given locally.”

“We’re excited with the study results presented by Dr. Ito at the 2024 European Respiratory Society. The data from these studies and other work conducted by RIGImmune demonstrate potent pan-viral activity for RIG-101 formulated with our NEED™ technology platform,” said Susan Sobolov, Ph.D., president of RIGImmune. “We have designed NEED™ to enable targeted delivery of a broad range of RNA therapeutics that aligns with the body’s own biological pathways, thereby minimizing toxicity risks. By validating RIG-101 in our NEED TM formulation technology in these pre-clinical systems that have demonstrated translation to the clinical setting, we are further committed to advancing RIG-101 intranasal to our first-in-human studies in mid-2025.”

Description of RIG-101 Study Results Presented at European Respiratory Society Sept 7 th – 11 th :

Title: Pan-antiviral effects of RIG-I agonists (RIG-101) against respiratory syncytial virus and human rhinovirus in nasal epithelium in vitro and mice in vivo Overview

• Prophylactic intranasal RIG-101 demonstrates potent antiviral activities against human rhinovirus (HRV) and respiratory syncytial virus (RSV), potentially preventing respiratory virus-induced asthma and similar respiratory disorders.

This study, led by Leah Daly of Imperial College London, showed that RIG-101 was able to induce interferon signaling in fully differentiated human nasal epithelium when delivered the day-prior and day-of viral exposure at apical site in air-liquid interface (ALI).

• In vivo testing demonstrated statistically significant reductions in HRV1B viral load and neutrophilia compared to pleconaril. Intranasal RIG-101 NEED™ (2mg/ml) was administered 4 and 1 day prior to exposure, with evaluations one day following exposure, and oral pleconaril (200 mg/kg) was administered up to one day prior to viral exposure.

Title: Effects of an anti-viral interferon booster, RIG-I agonist (RIG-101), on influenza infection in vitro and in vivo Overview

• Prophylactic intranasal RIG-101 offers signs of viral prevention efficacy against influenza infection, and demonstrated increased immune response
• In an oral presentation, researchers, led by Hugo Ombredane, Ph.D. student at Imperial College London, demonstrated that delivering intranasal RIG-101 prophylactically offered significant induction of type I/III interferon signalling and potent antiviral effects against influenza with antiviral effect comparable or superior to oseltamivir in both in vivo and in vitro models.
• RIG-101 significantly reduced viral load in vivo and in vitro , as well as strongly induced CXCL10, a surrogate marker of antiviral interferon production in vitro and prevented neutrophil accumulation, a sign of inflammation, in the nasal lavage in vivo .
• For this study, RIG-101 was delivered 4 days and 1 day prior to viral exposure in vitro and 3 days, 1 day and 1 hour prior to viral exposure in vivo , and evaluations were conducted 48 hours post-viral exposure in vitro and 1-5 days post-viral exposure in vivo .

Title: Adjutancy effects of a RIG-I agonist (RIG101) on H1N1 HA antigen intranasally vaccinated mice and human nasal epithelium/PBMCs co-culture Overview

• Adding prophylactic intranasal RIG-101 to the recombinant seasonal influenza hemagglutinin ( rHA ) vaccine more effectively reduced viral load and inflammation associated with the H1N1 HA subtype of influenza.
• RIG-101 combined with the recombinant seasonal influenza hemagglutinin ( rHA ) vaccine not only reduced viral load and inflammation associated with H1N1 HA, but also prevented virus-induced body weight loss compared with both HA antigen vaccination alone and the HA antigen vaccine plus CPG-ODN vaccine addition in a preclinical study led by Dr. Shyreen Hassibi of Imperial College London.
• An in vitro study involved peripheral blood mononuclear cells (PBMCs), which may include lymphocytes monocytes, natural killer cells (NK cells) and dendritic cells, cultured from the nasal cavity, and found that RIG-101 combined with H1N1 HA vaccination clearly enhanced the body’s natural production of immunogobulin M (IgM) antibodies, the first line of defence of the adaptive immune system, compared with H1N1 HA vaccination alone.

Presentation e-posters may be accessed on the Company Presentations page under the Corporate News section of the RIGImmune website as well as the European Respiratory Society Congress website.

About RIGImmune RIGImmune is a biopharmaceutical research company focused on the development of innovative RNA therapeutics to prevent or treat serious respiratory diseases with high unmet clinical needs. The company was co-founded by the prominent scientists, Drs. Akiko Iwasaki and Anna Pyle from Yale University, to advance the development of a novel class of oligonucleotides called stem-loop RNA therapeutics or “SLRs.” These SLRs were discovered in Dr. Pyle’s laboratory at Yale. In 2022, RIGImmune combined with a UK-based development company named SubIntro to develop non-lipid nanoparticle formulations for the effective delivery of a broad set of nucleic acid payloads directly to the respiratory tract. SubIntro was co-founded by the prominent research scientists and successful respiratory drug and formulation developers, Drs. Garth Rapeport, Kazuhiro Ito, and Jag Shur.

RIGImmune’s lead product development candidate is RIG-101, a stem loop RNA therapeutic that targets the RIG-I pathway to enhance the innate immune response against viral respiratory diseases. RIGImmune’s second product development candidate is RIG-301, an mRNA formulated with the NEED™ technology, targeting the CFTR mutation in cystic fibrosis patients. RIGImmune has internally developed a proprietary nano-emulsion delivery technology platform named NEED™ to effectively deliver RNA compounds without the need for lipid nanoparticle encapsulation.

About RIG-101 RIG-101 is a potent agonist of RIG-I, which results in the induction of the interferon pathway in the respiratory epithelium when administered locally. RIG-101 is formulated with the company’s NEED™ (Nano-Emulsion Enhanced Delivery) technology and will enter a Phase 1/2a clinical program in mid-2025 for the prevention of seasonal viral exacerbations of asthma. RIGImmune is developing RIG-101 for delivery by multiple routes of administration, including intranasal (IN), a solution for inhalation for lower respiratory tract delivery, intra-muscular, and subcutaneous. In the first clinical program for RIG-101, the product development candidate will be administered by the intranasal route for delivery directly to nasal epithelium. Extensive prior research by noted investigators has shown delivery directly to the nasal epithelium can be critical for comprehensive protection from a broad range of respiratory viruses.

About NEED™ ( N ano- E mulsion E nhanced D elivery) NEED™ is a non-lipid nanoparticle (LNP) formulation platform developed by RIGImmune to effectively deliver RNA directly to the respiratory mucosa and avoid the limitations and potential toxicity concerns associated with LNP delivery systems. The principal novelty of the NEED™ formulation technology is the ability to transform surfactants and natural fatty acids into a proprietary nano-emulsion complex that encapsulates a nucleic acid and protects the payload while controlling particle size and charge, and facilitates intracellular uptake when administered directly to the respiratory epithelium. The first clinical presentation of the NEED™ delivery platform will be an aqueous formulation for the intranasal delivery of RIG-101 to the upper respiratory tract. RIGImmune has shown that NEED™ can also be administered by multiple routes, including a solution for inhalation to the lower respiratory tract, subcutaneous, and intra-muscular. Initial research conducted by the company has shown the NEED™ delivery platform technology could be compatible and effective with a diverse range of RNA and DNA therapeutics.

Media Contact: Caren Begun TellMed Strategies 908-947-0500 x723 [email protected]

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Methylphenidate Extended Release Oral Presentations

Products affected - description.

• Aptensio XR extended release capsule, Rhodes, 10 mg, 90 count, NDC 42858-0401-45
• Aptensio XR extended release capsule, Rhodes, 15 mg, 90 count, NDC 42858-0402-45
• Aptensio XR extended release capsule, Rhodes, 20 mg, 90 count, NDC 42858-0403-45
• Aptensio XR extended release capsule, Rhodes, 30 mg, 90 count, NDC 42858-0404-45
• Aptensio XR extended release capsule, Rhodes, 60 mg, 90 count, NDC 42858-0407-45
• Methylphenidate CD extended release capsule, Amneal, 30 mg, 100 count, NDC 00115-1738-01
• Methylphenidate CD extended release capsule, Lannett, 30 mg, 100 count, NDC 00527-4581-37
• Methylphenidate CD extended release capsule, Teva, 10 mg, 100 count, NDC 00093-5295-01
• Methylphenidate CD extended release capsule, Teva, 20 mg, 100 count, NDC 00093-5296-01
• Methylphenidate CD extended release capsule, Teva, 30 mg, 100 count, NDC 00093-5297-01
• Methylphenidate CD extended release capsule, Teva, 40 mg, 100 count, NDC 00093-5298-01 - discontinued
• Methylphenidate CD extended release capsule, Teva, 60 mg, 100 count, NDC 00093-5293-01 - discontinued
• Methylphenidate CD extended release capsule, Teva, 50 mg 100 count, NDC 00093-5292-01 - discontinued
• Methylphenidate LA extended release capsule, Teva, 20 mg, 100 count, NDC 00093-5346-01
• Methylphenidate LA extended release capsule, Teva, 30 mg, 100 count, NDC 00093-5347-01
• Methylphenidate LA extended release capsule, Teva, 40 mg, 100 count, NDC 00093-5348-01
• Methylphenidate XR extended release capsule, Rhodes, 10 mg, 90 count, NDC 42858-0075-45
• Methylphenidate XR extended release capsule, Rhodes, 15 mg, 90 count, NDC 42858-0076-45
• Methylphenidate XR extended release capsule, Rhodes, 20 mg, 90 count, NDC 42858-0077-45
• Methylphenidate XR extended release capsule, Rhodes, 30 mg, 90 count, NDC 42858-0078-45
• Methylphenidate XR extended release capsule, Rhodes, 40 mg, 90 count, NDC 42858-0079-45
• Methylphenidate XR extended release capsule, Rhodes, 60 mg, 90 count, NDC 42858-0081-45
• Methylphenidate XR extended release capsule, Teva, 10 mg, 90 count, NDC 00591-3854-19
• Methylphenidate XR extended release capsule, Teva, 15 mg, 90 count, NDC 00591-3862-19
• Methylphenidate XR extended release capsule, Teva, 20 mg, 90 count, NDC 00591-3869-19
• Methylphenidate XR extended release capsule, Teva, 30 mg, 90 count, NDC 00591-3873-19
• Methylphenidate XR extended release capsule, Teva, 40 mg, 90 count, NDC 00591-3891-19
• Methylphenidate XR extended release capsule, Teva, 60 mg, 90 count, NDC 00591-3902-19
• Methylphenidate Hydrochloride extended release tablet, Camber, 18 mg, 100 count, NDC 31722-0952-01
• Methylphenidate Hydrochloride extended release tablet, Camber, 27 mg, 100 count, NDC 31722-0953-01
• Methylphenidate Hydrochloride extended release tablet, Camber, 36 mg, 100 count, NDC 31722-0954-01
• Methylphenidate Hydrochloride extended release tablet, Camber, 54 mg, 100 count, NDC 31722-0955-01
• Methylphenidate Hydrochloride extended release tablet, Lannett, 54 mg, 100 count, NDC 62175-0313-37
• Methylphenidate Hydrochloride extended release tablet, Sun Pharma, 18 mg, 100 count, NDC 57664-0606-88 - discontinued
• Methylphenidate Hydrochloride extended release tablet, Sun Pharma, 27 mg, 100 count, NDC 57664-0607-88 - discontinued
• Methylphenidate Hydrochloride extended release tablet, Sun Pharma, 36 mg, 100 count, NDC 57664-0608-88 - discontinued
• Methylphenidate Hydrochloride extended release tablet, Sun Pharma, 54 mg, 100 count, NDC 57664-0609-88 - discontinued
• Methylphenidate Hydrochloride extended release tablet, Teva, 18 mg, 100 count, NDC 62037-0725-01
• Methylphenidate Hydrochloride extended release tablet, Teva, 27 mg, 100 count, NDC 62037-0734-01
• Methylphenidate Hydrochloride extended release tablet, Teva, 36 mg, 100 count, NDC 62037-0726-01
• Methylphenidate Hydrochloride extended release tablet, Teva, 54 mg, 100 count, NDC 62037-0727-01
• Methylphenidate Hydrochloride extended release tablet, XLCare, 18 mg, 100 count, NDC 72865-0133-01
• Methylphenidate Hydrochloride extended release tablet, XLCare, 27 mg, 100 count, NDC 72865-0134-01
• Methylphenidate Hydrochloride extended release tablet, XLCare, 36 mg, 100 count, NDC 72865-0135-01
• Methylphenidate Hydrochloride extended release tablet, XLCare, 54 mg, 100 count, NDC 72865-0136-01

Reason for the Shortage

• Acella was not available to provide information.
• Adlon discontinued Adhansia XR in July 2022.
• Amneal discontinued the extended release tablets in March 2023. The company has the extended-release (CD) capsules available.
• Aytu BioPharma has Cotempla XR-ODT extended-release oral disintegrating tablets available. Cotempla is dose equivalent to methylphenidate hydrochloride extended-release (CD) capsules.
• Camber discontinued methylphenidate extended-release tablets.
• Ironhorse has Jornay PM available.
• Janssen has Concerta extended-release tablets available.
• KVK-Tech was not available to provide information
• Lannett has methylphenidate tablets on shortage due to increased demand and shortage of active ingredient. Lannett is shipping most presentations to forecast.
• Mallinckrodt has all presentations available.
• Patriot discontinued methylphenidate extended-release tablets (authorized generic) in January 2023.
• Rhodes has Aptensio XR capsules available.
• Sandoz has methylphenidate (LA) capsules and Ritalin LA capsules available.
• Sun Pharma discontinued methylphenidate extended-release tablets.
• Teva states the reason for the delay is manufacturing delay. Teva has the extended-release (LA) capsules temporarily unavailable. Teva discontinued the 40 mg, 50 mg, and 60 mg extended-release (CD) capsules in December 2023.
• Trigen has methylphenidate extended-release tablets available.
• Tris Pharma has Quillichew ER chewable tablets and Quillivant XR liquid available.
• Vertical has Relexxii tablets available.
• XLCare has methylphenidate extended-release tablets on shortage because the company is awaiting DEA allocation for active ingredient.

Available Products

• Aptensio XR extended release capsule, Rhodes, 40 mg, 90 count, NDC 42858-0405-45
• Aptensio XR extended release capsule, Rhodes, 50 mg, 90 count, NDC 42858-0406-45
• Concerta extended release tablet, Janssen, 18 mg, 100 count, NDC 50458-0585-01
• Concerta extended release tablet, Janssen, 27 mg, 100 count, NDC 50458-0588-01
• Concerta extended release tablet, Janssen, 36 mg, 100 count, NDC 50458-0586-01
• Concerta extended release tablet, Janssen, 54 mg, 100 count, NDC 50458-0587-01
• Cotempla XR-ODT oral disintegrating tablet, Aytu BioPharma, 17.3 mg, unit-dose blister pack, 30 count, NDC 70165-0200-30
• Cotempla XR-ODT oral disintegrating tablet, Aytu BioPharma, 25.9 mg, unit-dose blister pack, 30 count, NDC 70165-0300-30
• Cotempla XR-ODT oral disintegrating tablet, Aytu BioPharma, 8.6 mg, unit-dose blister pack, 30 count, NDC 70165-0100-30
• Jornay PM extended release capsule, Ironhorse, 100 mg, 100 count, NDC 71376-0205-03
• Jornay PM extended release capsule, Ironhorse, 20 mg, 100 count, NDC 71376-0201-03
• Jornay PM extended release capsule, Ironhorse, 40 mg, 100 count, NDC 71376-0202-03
• Jornay PM extended release capsule, Ironhorse, 60 mg, 100 count, NDC 71376-0203-03
• Jornay PM extended release capsule, Ironhorse, 80 mg, 100 count, NDC 71376-0204-03
• Methylphenidate CD extended release capsule, Amneal, 10 mg, 100 count, NDC 00115-1736-01
• Methylphenidate CD extended release capsule, Amneal, 20 mg, 100 count, NDC 00115-1737-01
• Methylphenidate CD extended release capsule, Amneal, 40 mg, 100 count, NDC 00115-1739-01
• Methylphenidate CD extended release capsule, Amneal, 50 mg, 100 count, NDC 00115-1740-01
• Methylphenidate CD extended release capsule, Amneal, 60 mg, 100 count, NDC 00115-1741-01
• Methylphenidate CD extended release capsule, Lannett, 10 mg, 100 count, NDC 00527-4579-37
• Methylphenidate CD extended release capsule, Lannett, 20 mg, 100 count, NDC 00527-4580-37
• Methylphenidate CD extended release capsule, Lannett, 40 mg, 100 count, NDC 00527-4582-37
• Methylphenidate CD extended release capsule, Lannett, 50 mg, 100 count, NDC 00527-4583-37
• Methylphenidate CD extended release capsule, Lannett, 60 mg, 100 count, NDC 00527-4584-37
• Methylphenidate LA extended release capsule, Mayne Pharma, 10 mg, 100 count, NDC 51862-0609-01
• Methylphenidate LA extended release capsule, Mayne Pharma, 20 mg, 100 count, NDC 51862-0610-01
• Methylphenidate LA extended release capsule, Mayne Pharma, 30 mg, 100 count, NDC 51862-0611-01
• Methylphenidate LA extended release capsule, Mayne Pharma, 40 mg, 100 count, NDC 51862-0612-01
• Methylphenidate LA extended release capsule, Mayne Pharma, 60 mg, 30 count, NDC 51862-0614-01
• Methylphenidate LA extended release capsule, Sandoz, 10 mg, 100 count, NDC 00781-2361-01
• Methylphenidate LA extended release capsule, Sandoz, 20 mg, 100 count, NDC 00781-2362-01
• Methylphenidate LA extended release capsule, Sandoz, 30 mg, 100 count, NDC 00781-2363-01
• Methylphenidate LA extended release capsule, Sandoz, 40 mg, 100 count, NDC 00781-2364-01
• Methylphenidate XR extended release capsule, Rhodes, 50 mg, 90 count, NDC 42858-0080-45
• Methylphenidate XR extended release capsule, Teva, 50 mg, 90 count, NDC 00591-3895-19
• QuilliChew ER extended-release chewable tablet, Tris Pharma, 20 mg, bottle, 100 count, NDC 24478-0074-01
• QuilliChew ER extended-release chewable tablet, Tris Pharma, 30 mg, bottle, 100 count, NDC 24478-0075-01
• QuilliChew ER extended-release chewable tablet, Tris Pharma, 40 mg, bottle, 100 count, NDC 24478-0076-01
• Quillivant XR extended-release oral powder for suspension, Tris Pharma, 5 mg/mL, 120 mL bottle, NDC 24478-0322-04
• Quillivant XR extended-release oral powder for suspension, Tris Pharma, 5 mg/mL, 150 mL bottle, NDC 24478-0323-05
• Quillivant XR extended-release oral powder for suspension, Tris Pharma, 5 mg/mL, 180 mL bottle, NDC 24478-0324-06
• Quillivant XR extended-release oral powder for suspension, Tris Pharma, 5 mg/mL, 60 mL bottle, NDC 24478-0321-02
• Relexxii extended release tablet, Vertical, 18 mg, 100 count, NDC 68025-0095-10
• Relexxii extended release tablet, Vertical, 27 mg, 100 count, NDC 68025-0096-10
• Relexxii extended release tablet, Vertical, 36 mg, 100 count, NDC 68025-0097-10
• Relexxii extended release tablet, Vertical, 45 mg, 30 count, NDC 68025-0088-30
• Relexxii extended release tablet, Vertical, 54 mg, 100 count, NDC 68025-0098-10
• Relexxii extended release tablet, Vertical, 63 mg, 30 count, NDC 68025-0089-30
• Relexxii extended release tablet, Vertical, 72 mg, 30 count, NDC 68025-0084-30
• Ritalin LA extended release capsule, Sandoz, 10 mg, 100 count, NDC 00078-0424-05
• Ritalin LA extended release capsule, Sandoz, 20 mg, 100 count, NDC 00078-0370-05
• Ritalin LA extended release capsule, Sandoz, 30 mg, 100 count, NDC 00078-0371-05
• Ritalin LA extended release capsule, Sandoz, 40 mg, 100 count, NDC 00078-0372-05
• Methylphenidate Hydrochloride extended release tablet, Lannett, 18 mg, 100 count, NDC 62175-0310-37
• Methylphenidate Hydrochloride extended release tablet, Lannett, 27 mg, 100 count, NDC 62175-0311-37
• Methylphenidate Hydrochloride extended release tablet, Lannett, 36 mg, 100 count, NDC 62175-0312-37
• Methylphenidate Hydrochloride extended release tablet, Mallinckrodt, 27 mg, 100 count, NDC 00406-0127-01
• Methylphenidate Hydrochloride extended release tablet, Mallinckrodt, 36 mg, 100 count, NDC 00406-0136-01
• Methylphenidate Hydrochloride extended release tablet, Mallinckrodt, 54 mg, 100 count, NDC 00406-0154-01
• Methylphenidate Hydrochloride extended release tablet, Trigen, 18 mg, 100 count, NDC 13811-0706-10
• Methylphenidate Hydrochloride extended release tablet, Trigen, 27 mg, 100 count, NDC 13811-0707-10
• Methylphenidate Hydrochloride extended release tablet, Trigen, 36 mg, 100 count, NDC 13811-0708-10
• Methylphenidate Hydrochloride extended release tablet, Trigen, 45 mg, 30 count, NDC 13811-0711-30
• Methylphenidate Hydrochloride extended release tablet, Trigen, 54 mg, 100 count, NDC 13811-0709-10
• Methylphenidate Hydrochloride extended release tablet, Trigen, 63 mg, 30 count, NDC 13811-0700-30
• Methylphenidate Hydrochloride extended release tablet, Trigen, 72 mg, 30 count, NDC 13811-0710-30

Estimated Resupply Dates

• Camber has methylphenidate 18 mg, 27 mg, 36 mg, and 54 mg XR capsules on allocation.
• Lannett has methylphenidate 54 mg extended-release tablets on back order and the company cannot estimate a release date. The 30 mg extended-release (CD) capsules are on intermittent back order and the company is releasing supplies as they become available.
• Rhodes has Aptensio XR 10 mg and 20 mg, capsules on back order and the company cannot estimate a release date. Aptensio XR 15 mg, 30 mg, and 60 mg capsules are available but with short dating (June 2025 for the 15 mg and 30 mg capsules and April 2025 for the 60 mg capsules). Generic methylphenidate 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 60 mg extended-release capsules on back order and the company cannot estimate a release date.
• Teva has methylphenidate 18 mg, 27 mg, 36 mg, and 54 mg extended-release tablets on intermittent back order and the company is releasing supplies as they become available. Teva has 10 mg, 20 mg, and 30 mg extended-release (CD) capsules on back order and the company cannot estimate a release date. The 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 60 mg extended-release (XR) capsules are on intermittent back order and the company is releasing supplies as they become available.
• XLCare has methylphenidate extended-release tablets on back order and the company cannot estimate a release date.

Implications for Patient Care

• Lannett and Mallinckrodt extended-release tablets have a therapeutic equivalence rating of BX in FDA's Orange Book. The available data on these generic drug products are insufficient for FDA to determine therapeutic equivalence with Concerta
• The CDC has issued a health advisory regarding potential disrupted access to care in patients taking prescription stimulant medications and possible increased risks for injury and overdose. The health advisory can be found at https://emergency.cdc.gov/han/2024/han00510.asp

Updated September 8, 2024 by Elyse MacDonald, PharmD, MS, BCPS. Created December 20, 2022 by Leslie Jensen, PharmD, Drug Information Specialist. © 2024, Drug Information Service, University of Utah, Salt Lake City, UT.

Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. ASHP and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this Bulletin. Neither ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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