Delving into the Latest Updates on Salbutamol sulfate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

ALBUTEROL, ALBUTEROL SULFATE, Salbutamol

+ [54]

Target

β2-adrenergic receptor

Action

agonists

Mechanism

β2-adrenergic receptor agonists(Beta-2 adrenergic receptor agonists)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesRespiratory Diseases+ [1]

Active Indication

Asthma, Exercise-InducedBronchial SpasmAirway Obstruction+ [6]

Inactive Indication

airway diseaseAsthma chronicChildhood asthma+ [2]

Originator Organization

Active Organization

+ [4]

Inactive Organization

Boehringer Ingelheim GmbH

Merck Sharp & Dohme Corp.Pharmobedient, Inc.

+ [3]

License Organization-

Drug Highest PhaseApproved

First Approval Date

Japan (13 Jan 1973),

Airway ObstructionAsthmaBronchitis+ [2]

RegulationOrphan Drug (United States)

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Structure/Sequence

Molecular FormulaC13H23NO7S

InChIKeyOVICLFZZVQVVFT-UHFFFAOYSA-N

CAS Registry51022-70-9

Peripheral nerve injuries are commonly encountered in clinical practice. Peripheral nerve injuries most commonly result in serious problems affecting quality of life. The present study is designed to research the possible neuroprotective effects of Ankaferd blood stopper (ABS), platelet-rich plasma (PRP), and Momordica charantia (MC) on regeneration using unbiased stereological techniques. In total, 30 female 8-10 week Sprague Dawley rats were randomly divided into five equal groups; control (CG), the group exposed to sciatic nerve resection (Gap) (CGG), additionally following the surgical process ABS, MC, and PRP were injected into collagen tube (ABSG, MCG, PRPG). Nucleator and fractionator methods were used to estimate the number of myelinated and unmyelinated axons, axon area, and myelin sheath thickness. Also, an electron microscopic evaluation was performed. Regarding the number of myelinated axons, significant increases were found in the ABSG, MCG, and PRPG compared with CG (p < 0.05). The protective effects of ABS, PRP, and MC on peripheral nerve regeneration in experimental models in rats were shown using electrophysiological and stereological assessment parameters.

01 Dec 2025·FOOD CHEMISTRY

Quantitative determination of salbutamol residues using a fluorescence immunochromatography assay

Article

Author: Chen, Cuicui ; Zhong, Shuhai ; Liang, Huankun ; Jia, Qiang ; Li, Laiqing ; Lai, Hongrui ; Lu, Yanhong

The illegal use of salbutamol (SAL) in livestock leaves residues in animal-derived foods that pose direct health risks to consumers. Given the lack of rapid, on-site quantitative detection methods for SAL, we hypothesized that a fluorescence immunochromatographic assay (FICA) could be developed to achieve the ultrasensitive, specific, and portable detection of SAL residues in animal-derived foods. We successfully established such a FICA, and its sensitivity was 5.0 pg/mL. FICA strips showed high specificity for SAL with low cross-reactivity (except for clenbuterol). The average recoveries of SAL from animal-derived foods (beef, eggs, and milk) ranged from 82.9 % to 91.8 %. Moreover, the results of the FICA method strongly correlated with those of HPLC (Pearson's r = 0.99). These findings support our initial hypothesis that the FICA strips can be directly applied to the on-site, rapid screening of SAL residues in animal-derived foods, providing technical support for food safety supervision.

01 Nov 2025·Current pediatric reviews

Insights from Overviewing Selective International Guidelines for Pediatric Asthma

Review

Author: Ng, Daniel K.K. ; Leung, Alexander K.C. ; Hon, Kam L.E. ; Chiu, Wa K.

Background::

Asthma is a chronic atopic and inflammatory bronchial disease characterized by recurring symptoms and, episodic reversible bronchial obstruction and easily triggered bronchospasms. Asthma often begins in childhood. International guidelines are widely accepted and implemented; however, there are similarities and differences in the management approaches. There is no national guideline in many cities in Asia. This review aims to provide a practical perspective on current recommendations in the management of childhood asthma, specifically in the following aspects: diagnosis, classification of severity, treatment options, and asthma control, and to provide physicians with up-to-date information for the management of asthma

Methods::

We used the PubMed function of Clinical Queries and searched keywords of “Asthma”, “Pediatric,” AND “Guidelines” as the search engine. “Clinical Prediction Guides”, “Etiology”, “Diagnosis”, “Therapy,” “Prognosis,” and “Narrow” scope were used as filters. The search was conducted in November 2022. The information retrieved from this search was used in compiling the present article.

Results::

Diagnosis is clinically based on symptom pattern, response to therapy with bronchodilators and inhaled corticosteroids, and spirometric pulmonary function testing (PFT). Asthma is classified in accordance with symptom frequency, peak expiratory flow rate (PEFR), forced expiratory volume in one second (FEV1), atopic versus nonatopic etiology, where atopy means a predisposition toward a type 1 hypersensitivity reaction. Asthma is also classified as intermittent or persistent (mild to severe). Unfortunately, there is no disease cure for asthma. However, symptoms can be prevented by trigger avoidance and suppressed with inhaled corticosteroids. Antileukotriene agents or long-acting beta-agonists (LABA) may be used together with inhaled corticosteroids if symptoms of asthma are not controlled. Rapidly worsening symptoms are usually treated with an inhaled short-acting beta-2 agonist (SABA, e.g., salbutamol) and oral corticosteroids. Intravenous corticosteroids and hospitalization are required in severe cases of asthma attacks. Some guidelines also provide recommendations on the use of biologics and immunotherapy.

Conclusion::

Asthma is diagnosed clinically, with supporting laboratory testing. Treatment is based on severity classification, from intermittent to persistent. Inhaled bronchodilator and steroid anti-inflammatory form the main stay of management.

127

News (Medical) associated with Salbutamol sulfate

02 Dec 2025

·www.globenewswire.com

Amneal Receives U.S. FDA Approval for Albuterol Sulfate Inhalation Aerosol

Represents second complex respiratory therapeutic product approval in Q4 2025BRIDGEWATER, N.J., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (Nasdaq: AMRX) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s albuterol sulfate inhalation aerosol (90 mcg per actuation). The product is the generic equivalent of PROAIR® HFA (albuterol sulfate inhalation aerosol), a registered trademark of Teva Respiratory LLC. This approval follows the Company’s FDA approval of its beclomethasone dipropionate inhalation aerosol, a generic equivalent of QVAR® (beclomethasone dipropionate inhalation aerosol), further advancing Amneal’s entry into complex inhaled and respiratory drug delivery. Together, these milestones underscore the Company’s momentum in building a differentiated, high-value respiratory portfolio supported by its state-of-the-art manufacturing platform. “Securing two significant inhalation approvals this quarter—first beclomethasone dipropionate and now albuterol—highlights the tremendous progress our teams have made in a highly complex respiratory category,” said Dr. Srinivas Kone, Senior Vice President, Chief Scientific Officer – Affordable Medicines. “These achievements are the result of years of hard work, engineering excellence, and investment in our respiratory platform, and they position Amneal to deliver meaningful growth and patient impact.” Albuterol sulfate inhalation aerosol is indicated for the treatment or prevention of bronchospasm in adults and children 12 years of age and older with reversible obstructive airway disease. The most common adverse reactions (≥3.0% and >placebo) are headache, tachycardia, pain, dizziness, pharyngitis, and rhinitis. For full prescribing information, see package insert here. According to IQVIA® U.S. annual sales for albuterol sulfate inhalation aerosol for the 12 months ended September 2025 were approximately $1.5 billion. PROAIR® HFA and QVAR® are registered trademarks of Teva Respiratory LLC. About AmnealAmneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 290 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com and follow us on LinkedIn. Cautionary Statement on Forward-Looking StatementsCertain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof. Investor Contact Anthony DiMeoVP, Investor Relations anthony.dimeo@amneal.com Media ContactBrandon SkopSr. Director, Corporate Communicationsbrandon.skop@amneal.com

Drug Approval

30 Oct 2025

·www.globenewswire.com

Ritedose Now Offers the Largest Nebulized Drug Portfolio in the U.S.: FDA Approves the Company to Manufacture Generic Tobramycin Inhalation Solution

- Generic Tobramycin Inhalation Solution marks the first cystic fibrosis (CF) product in the Company’s portfolio-Antibiotic is primarily used for chronic Pseudomonas aeruginosa infections in patients with CF COLUMBIA, S.C., Oct. 30, 2025 (GLOBE NEWSWIRE) -- The Ritedose Corporation (Ritedose) announced that the U.S. Food and Drug Administration (FDA) approved its manufacturing and distribution of Tobramycin Inhalation Solution to treat patients six years and older with infections of Pseudomonas aeruginosa, a common bacterial infection among cystic fibrosis patients. Tobramycin will be marketed by Ritedose Pharmaceuticals, the generics division of Ritedose (the largest sterile contract development manufacturing organization (CDMO) in the U.S., specializing in aseptic unit-dose medication production using Blow-Fill-Seal (BFS) technology). Ritedose licensed the drug’s Abbreviated New Drug Application (ANDA) from Hikma Pharmaceuticals. “With the addition of Tobramycin, Ritedose now provides the largest nebulized drug portfolio in the country,” said CEO of Ritedose Jody Chastain. “Our recent investments in expanded facilities, cold chain processes and an additional packaging line have given us unparalleled capabilities in sterile manufacturing.” Tobramycin is an aminoglycoside antibiotic indicated for the treatment of serious bacterial infections, including Pseudomonas aeruginosa (P.aeruginosa), in adults and pediatric patients six years of age and older. The Ritedose formulation is preservative-free and packaged as 300 mg doses in 5 ml ampules, to be administered through a nebulizer device. The medication is now available for purchase. “Now with Tobramycin in our portfolio, we can provide affordable, safe and reliable medications to patients with serious bacterial infections, expanding access to this critical therapy,” continued Chastain. “We’re also proud to strengthen supply chain resilience with the addition of a broad-spectrum antibiotic that is produced here in the United States.” Tobramycin Inhalation Solution is the third generic drug announced by Ritedose this year. In April, Ritedose Pharmaceuticals received approval to manufacture generic Formoterol Fumarate Inhalation Solution for the maintenance treatment of chronic obstructive pulmonary disease (COPD). In March, Ritedose received approval for Albuterol Sulfate Inhalation Solution, 0.5% (2.5 mg/0.5 mL)*, for patients over 12 years of age suffering from acute attacks of bronchospasms or reversible obstructive airway disease. The addition rounded out Ritedose’s complete portfolio of albuterol treatments and addressed a nationwide shortage of the essential drug. *Potency expressed as albuterol, equivalent to 3 mg of albuterol sulfate. About The Ritedose Corporation Ritedose is the largest sterile contract development manufacturing organization (CDMO) in the US specializing in sterile Blow Fill Seal (BFS) technology that ensures sterile, consistent, and safe unit dose delivery. The company’s process guides the development of molecules from clinical trials to commercialization of branded and generic inhalation and ophthalmic medications. With a focus on quality, innovation, and customer satisfaction, Ritedose partners with leading pharmaceutical companies to deliver safe, effective, and reliable medications that improve patient outcomes. Ritedose: Passion and Precision with a Purpose. For more information visit Ritedose.com Media Contact: Alex Keown630-346-5141akeown@inspire-agency.comOn Behalf of Ritedose A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/39b2ff09-2585-4764-93e1-4dd9766dc9fc

Drug Approval

16 Oct 2025

·www.businesswire.com

Aptar Digital Health Announces FDA 510(k) Clearance for HeroTracker ® Sense, a Connected Add-On Device for Metered-Dose Inhalers

CRYSTAL LAKE, Ill.--(BUSINESS WIRE)--Aptar Digital Health, a global leader in digital health solutions enhancing the patient experience, today announced that the U.S Food and Drug Administration (FDA) has granted 510(k) clearance for HeroTracker® Sense as a Class II medical device. This milestone recognizes HeroTracker® Sense - a Bluetooth-enabled sensor - as an innovative connected add-on for pressurized Metered Dose Inhalers (pMDIs), transforming traditional inhalers into smart, data-driven devices for patients and healthcare professionals. Designed for individuals aged 12 and above, HeroTracker® Sense is compatible with several commonly prescribed asthma and chronic obstructive pulmonary disease (COPD) medications, including Ventolin® HFA, Advair®, and certain albuterol and fluticasone/salmeterol inhalers. Integrated within Aptar Digital Health’s Respiratory Disease Management Platform, HeroTracker® Sense supports users in managing their respiratory health through comprehensive medication and symptom management. The platform delivers real-time usage tracking, personalized reminders and educational resources via an intuitive mobile application, encouraging behavior change and adherence to prescribed therapies. By enabling patients to monitor inhaler techniques and receive instant feedback, the platform aims to support improved respiratory health. “By combining inhalation therapy with advanced digital health solutions, we aim to support patients in improving adherence and providing healthcare professionals with actionable insights,” said Raffi Krikorian, SVP Global Quality and Regulatory Affairs at Aptar Digital Health. “Our platform has previously shown promise in supporting asthma management and reducing reliance on rescue medication1. The FDA's clearance allows us to enable broader access to our connected solutions for patients seeking to better manage their respiratory health.” Asthma remains a significant health concern in the United States, affecting an estimated 26.8 million people across the United States2. It stands among the leading causes of missed school and workdays, contributing to an economic burden of nearly $82 billion each year in medical costs, lost productivity and premature death. With the FDA clearance of HeroTracker® Sense, individuals living with asthma or COPD will now have access to an innovative and user-friendly solution for tracking, evaluating and recording their medication use, aiming to improve treatment outcomes and quality of life. About HeroTracker® Sense HeroTracker® Sense is a connected add-on device attached to a compatible pressurized Metered Dose Inhaler (pMDI) for patients aged 12 and above. It functions as an electronic data capture accessory for monitoring and recording individual inhalation actuation, shake, orientation, coordination, and inspiratory strength and duration during prescribed inhaler use. HeroTracker® Sense is designed to operate with specific pMDI and medication indicated on the label. It does not provide information on the remaining quantity of medication in the inhaler and does not include a dose-counting function. HeroTracker® Sense does not provide spirometry measurements. HeroTracker® Sense may be used in clinical practice or clinical trials, where specialists require insights into whether a patient has used their prescribed medication or to assess inhalation technique. About Aptar Digital Health Aptar Pharma's Digital Health division is part of AptarGroup, Inc. (NYSE:ATR), a global leader in drug and consumer product dosing, dispensing and protection technologies. Aptar Digital Health creates end-to-end solutions to enhance patient experiences every day, leveraging a holistic ecosystem of digital interventions. Amplified by an industry-leading portfolio of products and solutions, Aptar Digital Health’s offering combines mobile and web apps, Software-as-Medical-Device, connected drug delivery systems, advanced data analysis services, and patient onboarding and training solutions to actively empower patients and create a positive treatment journey. Aptar is headquartered in Crystal Lake, Illinois and has more than 13,000 dedicated employees in 20 countries. For more information, visit www.aptardigitalhealth.com and www.aptar.com. 1 Bijlani A, Mauger D, Goodheart C, dOrsay G, Suman J. Impact of a digital therapeutic on adult asthma. Eur J Public Health. 2023 Oct 24;33(Suppl 2):ckad160.823. doi: 10.1093/eurpub/ckad160.823. PMCID: PMC10597004. 2 Most Recent National Asthma Data | CDC

100 Deals associated with Salbutamol sulfate

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Salbutamol sulfate	R03CC02 R03AC02	DB01001

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Asthma, Exercise-Induced	United States	Schering Corp.	01 May 1981
Bronchial Spasm	United States	Schering Corp.	01 May 1981
Airway Obstruction	Japan	GSK Plc	13 Jan 1973
Asthma	Japan	GSK Plc	13 Jan 1973
Bronchitis	Japan	GSK Plc	13 Jan 1973
Pulmonary Emphysema	Japan	GSK Plc	13 Jan 1973
Pulmonary Tuberculosis	Japan	GSK Plc	13 Jan 1973

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute asthma	NDA/BLA	Canada	Intech Biopharm Ltd.	-
Persistent asthma	Phase 3	United States	Teva Branded Pharmaceutical Products R&D, Inc.	01 Oct 2010
Childhood asthma	Phase 3	United States	Teva Branded Pharmaceutical Products R&D, Inc.	10 Jun 2006
Pulmonary Disease, Chronic Obstructive	Phase 3	United States	GSK Plc	01 Sep 2004
Pulmonary Disease, Chronic Obstructive	Phase 3	Puerto Rico	GSK Plc	01 Sep 2004
Idiopathic Pulmonary Fibrosis	Phase 1	United Kingdom	GSK Plc	01 Apr 2012
airway disease	Phase 1	-	Merck Sharp & Dohme Corp.	01 Mar 2009
Mild asthma	Clinical	India	Intech Biopharm Ltd.	15 Aug 2022
Mild asthma	Clinical	Taiwan Province	Intech Biopharm Ltd.	15 Aug 2022
Asthma chronic	Clinical	United States	AstraZeneca PLC	01 Nov 2006

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04901715 (CTgov)	Early Phase 1	Ciliary Motility Disorders	27	Technetium99m - Sulfur Colloid (Tc99m-SC)+Albuterol (Genotypes Associated With Severe Phenotype)	epgrqseuad(qqcdudbwun) = hfztzqjkhz kzlfpworia (qiqcmtywdi, odafujqkus - gafanykmmn) View more	-	05 Sep 2025
				Technetium99m - Sulfur Colloid (Tc99m-SC)+Albuterol (Healthy Control)	epgrqseuad(qqcdudbwun) = shvayhcfev kzlfpworia (qiqcmtywdi, mkzhutlxkr - mpwzwmhkoj) View more
NCT05505734 (BATURA, Literature \| Pubmed \| NEWS) Manual	Phase 3	Mild asthma	2,421	Albuterol-Budesonide	gpfpdxhcbg(fjerqvpmzx) = qriokoyzqd ujdixoswlt (mfjsezlgeg ) View more	Positive	19 May 2025
				Albuterol	gpfpdxhcbg(fjerqvpmzx) = youprxfarp ujdixoswlt (mfjsezlgeg ) View more
NCT05555290 (ALTA Study, ATS2025)	Phase 3	Airway Obstruction fractional exhaled nitric oxide	84	Albuterol-Budesonide 180/160 µg	nylkyikrcw(tjhlbflvkn) = brnfmxhlfb bshebazbcd (rnzpgadpes ) View more	Positive	16 May 2025
NCT03556683 (CTgov)	Not Applicable	Asthma	24	7% Hypertonic Saline+salbutamol (Early & Late-Phase Hypertonic Saline (HS) 7% (Cohort 1))	johzuxovam(ztobcrdvro) = ayynxfijpk pxitzaznaf (paulwiyuss, 8.3) View more	-	04 May 2025
				7% Hypertonic Saline+salbutamol (Hypertonic Saline (HS) 3% and 7% (Cohort 2))	tmtpetjreu(bfoezkvwin) = essjclqwos mupxoycwow (iypawubslv, npcigfcqfw - xubzvvksvs) View more
NCT05087693 (CTgov)	Phase 4	Asthma \| Asthma, Exercise-Induced	18	Ozone+salbutamol (Exercising in Ozone Following Salbutamol Inhalation)	ijaggflnjc(sohkrqerrv) = mstzntecdm rffgowrecw (izxakkryqg, irqqmhzjxm - qbheogoohl) View more	-	14 Mar 2025
				Filtered Air+salbutamol (Exercising in Filtered Air Following Salbutamol Inhalation)	ijaggflnjc(sohkrqerrv) = hcqmzelfkw rffgowrecw (izxakkryqg, eqljmmubol - zmhyseyiby) View more
NCT03924635 (CTgov)	Phase 4	Asthma \| airway disease	42	salbutamol+SYMBICORT (SYMBICORT as Maintenance and Reliever Treatment)	ewhtgqdnli(fbuhcdghum) = wuolzuhxzc uwaslysxou (yrnjplihyn, bbldxyuxam - juioqegnlr) View more	-	22 Jan 2025
				salbutamol+SYMBICORT (SYMBICORT as Maintenance, Salbutamol as Reliever Treatment)	ewhtgqdnli(fbuhcdghum) = kfjfdhqnbj uwaslysxou (yrnjplihyn, oinmhdmcgh - gowicfkxnc) View more
NCT04159519 (SHAMAL, CTgov)	Phase 4	Asthma \| Eosinophilic Asthma	170	salbutamol+Symbicort+benralizumab (Treatment Reduction)	yigvctqxgp = fqwtouulnm emyloqyoxz (yvatjuatnu, pglrfxumde - tyahoadrsa) View more	-	09 Jan 2025
				salbutamol+Symbicort+benralizumab (Reference)	yzjbvbxsxl(xxvcvvirmo) = iuxrliuxct gmqfwhhcoe (gypbmqhqnv, 0.0677) View more
NCT04276233 (PRISM, CTgov)	Phase 4	Asthma \| Eosinophilic Asthma	100	Mepolizumab	wrfyyavqlq = ofdildevgb cvwdupkcnr (ivqbbjytnj, gvxufofuek - xmrknzlyll) View more	-	10 Dec 2024
NCT03199976 (CTgov)	Phase 4	Asthma \| Airway Obstruction \| Asthmatic bronchitis	80	Tiotropium Bromide+salbutamol (Tiotropium Bromide & Salbutamol)	vvmxljukps(huwxocflmq) = yrvwwkjsca mijsatyhri (rvnqmvuigi, ajybgrvdhg - leuiapfxej) View more	-	19 Sep 2024
				salbutamol+Fluticasone Propionate (Fluticasone Propionate & Salbutamol)	vvmxljukps(huwxocflmq) = eukwctujis mijsatyhri (rvnqmvuigi, efjmxfmgwe - cruwlprygh) View more
NCT02508311 (CTgov)	Phase 4	Respiratory Paralysis \| Spinal Cord Injuries	1	Oral Albuterol Extended Release (Active Oral Beta-2)	mbebxxxdce(qrimbwblmu) = xlhvmagzes mzlixfaaho (pqjbakmnyq, sjuydrrxbe - kkaeyobgsl) View more	-	07 May 2024
				Placebo (Placebo)	mbebxxxdce(qrimbwblmu) = srapcvnmwh mzlixfaaho (pqjbakmnyq, bdnyxebwag - wyetajxhjo) View more