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Federal Circuit Finds Against Generics Where Hatch-Waxman's Full Five-Year Extension Fixes Delay For Pharmaceutical FDA-Review
01 Apr 2025 01:32 GMT
… balance in the pharmaceutical industry by incentivizing drugs makers to … ’340 patent”) on “sugammadex,” which issued on December 30 … applied for FDA approval of sugammadex. While the FDA approval was … 28, 2014. The FDA cleared sugammadex on December 15, 2015 …
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Human medicines European public assessment report (EPAR): Sugammadex Fresenius Kabi, sugammadex, Date of authorisation: 15/07/2022, Revision: 1, Status: Authorised
25 Mar 2025 22:54 GMT
… an anaesthetist (a doctor specialised in anaesthesia). Sugammadex Fresenius Kabi is … contact your doctor or pharmacist.
How does Sugammadex Fresenius Kabi … details
Name of medicine
Sugammadex Fresenius Kabi
Active substance
sugammadex sodium
International …
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January - March 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
05 Mar 2025 21:57 GMT
Bridion (sugammadex) injection
Arteriospasm coronary … Counseling Information,” and “Medication Guide,” sections of the …
Methylphenidate
Methylphenidate hydrochloride
Drug interaction between CNS … .
Example: Inlyta labeling
FDA determined that no action …
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Venus Remedies receives marketing authorization for Sugammadex from Philippines
04 Mar 2025 14:03 GMT
… critical care, Venus Remedies, and CEO, Venus Medicine Research Centre shared, … Remedies holds marketing authorizations for several crucial drugs in the Philippines. Sugammadex … such advanced medicines globally."
Overall, the pharmaceutical market in …
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Venus Remedies gets marketing nod for Sugammadex in Philippines
04 Mar 2025 12:21 GMT
… Remedies on Tuesday said it has received marketing authorisation for a medication … ASEAN market, Venus Remedies said in a statement.
Sugammadex is a selective … traditional agents, Sugammadex directly encapsulates and inactivates these drugs, offering a …
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Sugammadex Safe, Effective Post Surgery in Myasthenia Gravis
18 Feb 2025 17:58 GMT
… of 873 patients needed immunoglobulin treatment (n = 17) or plasma exchange … ;news/mercks-bridion-sugammadex-receives-fda-approval-for-the-reversal-of … -adults-undergoing-surgery/
5. Sugammadex. DrugBank. Accessed February 17, 2025. https …
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Blockade-Reversal Choice Shifts to Sugammadex in Renal Issue
17 Feb 2025 09:09 GMT
… a combination of rocuronium and sugammadex, those receiving cisatracurium and neostigmine … for attending anesthesiologists.
For rocuronium-sugammadex vs rocuronium-neostigmine, 41.7% … the University of Arkansas for Medical Sciences in Little Rock, Arkansas …
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Better patient information would improve consent process for anaesthetic drugs
31 Dec 2024 12:19 GMT
… and more accessible information about medicines for patients.1 As an … of perioperative drugs, particularly as we cannot always predict every medication that … operation.
A key example is sugammadex, a neuromuscular …
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Intrathecal Morphine and Ropivacaine for Quality of Recovery After Laparoscopic Colorectal Surgery: A Randomized Controlled Trial
18 Dec 2024 09:37 GMT
… 1) allergy or contraindication to trial medication; (2) contraindications to … a standardized protocol: initial treatment with rapid crystalloid infusion … mL. When indicated, sugammadex 2 mg/kg … reporting parallel group randomized trials. BMJ. 2010;340: …
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FDA Approved Drug Products Approval List November 2024
17 Dec 2024 07:53 GMT
Approval Date Drug Name Submission Active … 213112 SUPPL-12 TACROLIMUS CONCORD BIOTECH LTD Labeling Approval 11… BLUEPRINT MEDICINES Labeling Approval 11/08/2024 SUGAMMADEX … SUGAMMADEXANDA #213915 ORIG-1 SUGAMMADEX MYLAN PHARMS INC
Tentative …