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Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act
13 Sep 2023 02:34 GMT
… 47;30/14)
The Medicines Company
Cleviprex (clevidipine) IV emulsion … (PDF - 75KB)*
Sunovion Pharmaceuticals
Xopenex (levalbuterol HCl) Inhalation Solution
6 …
Egalet US, Inc. (formerly Luitpold Pharmaceuticals, Inc.)
Sprix (ketorolac tromethamine) Nasal …
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Akorn Pharmaceuticals Recalls 70+ Drugs Due to Company Shutdown
27 Apr 2023 06:57 GMT
Akorn Operating Company LLC, which filed for Chapter 7 bankruptcy on February 23, 2023, has ceased all operations and terminated employees of all its domestic US sites. As a result of the closures and discontinuation of the Quality activities of the …
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Get Relief With the Most Common Asthma Medications
12 May 2023 19:28 GMT
… but learning what the treatment options are can help alleviate … These can be in pill form or used as inhalers … forms of SABA medications include:
Albuterol (Ventolin)
Levalbuterol (Xopenex)
Albuterol and … In January 2023, the FDA approved Airsupra, which can …
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Pharmacies, Hospitals Facing Shortage of Asthma Drug Albuterol
09 Mar 2023 14:33 GMT
… of liquid albuterol, Nephron Pharmaceuticals, has had manufacturing issues … various medications, according to the U.S. Food and Drug … liquid albuterol available to doctors, such as Xopenex (levalbuterol), Mora said … risk they’ll need treatment in a hospital or …
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A Drug Used To Treat Asthma Attacks Is In Short Supply And The Shortage Is Likely To Get Worse
09 Mar 2023 00:46 GMT
… the medication in the US — Akorn and Nephron Pharmaceuticals — … under the brand name Xopenex) and ipratropium bromide… their doctor about increasing their medication dosages of other drugs, … that may require treatment with rescue medications like liquid …
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Bronchial Spasms Treatment Market Size, Share, Price, Trends, Growth, Analysis, Report & Forecast 2023-2031
24 Jan 2023 08:12 GMT
… spasms treatment market growth. In addition, surging efforts by pharmaceutical … :
Short-Acting Bronchodilators
Levalbuterol (Xopenex, Xopenex HFA)
Albuterol (AccuNeb, Proventil … clinical trials and to innovate more efficient therapeutics and medications …
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What are some medications for managing emphysema?
31 Jan 2023 13:14 GMT
… learn more about medications that doctors may prescribe to …
albuterol (Ventolin)
levosalbutamol (Xopenex HFA)
metaproterenol
terbutaline (Marex … than using either medication alone.
Some drugs available include: … go home.
Other treatments, including surgery and …
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Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2012 – present
18 Sep 2024 16:26 GMT
Drug Sponsor
Sponsor
Medical Review
Clinical Pharmacology Review
Statistical …
Golimumab - Simponi
Janssen Biotech, Inc.
Medical (PDF - 3.1 MB … MB)
PREA
Levalbuterol hydrochloride - Xopenex
Oak Pharmaceuticals
Medical (PDF - 8 MB …
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Ninety Percent of Patients Can't Use Inhalers Correctly, Digital Inhaler CapMedic Receives FDA Clearance to Change That
27 Jan 2020 17:13 GMT
… . It is also the only FDA-cleared wireless technology that empowers … drug deposition studies showing a tenfold improvement in the delivery of medication … ®, Advair®, FLOVENT®, DULERA®, Proventil® Asmanex®, Xopenex®, Alvesco®, and Atrovent®.
"Our …
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Momenta Pharmaceuticals Appoints Dr. Donna Grogan to Board of Directors
19 Sep 2019 12:00 GMT
… numerous investigational new drug applications and marketing … product approvals including Lunesta®, Xopenex HFA®, Brovana™ and … (tafamidis) for the treatment of the rare neurologic … of Medicine, III. About Momenta Momenta Pharmaceuticals is a biotechnology …