-
July - September 2024 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
30 Dec 2024 19:56 GMT
… wrong drug errors
FDA is evaluating the need for regulatory action.
Cubicin (daptomycin … for injection)
Cubicin … granules), co-packaged
Drug-induced liver injury
FDA is evaluating the need …
-
ANDA Approvals - New Drug Applications and 505(b)(2) Applications: Third Quarter
15 Nov 2024 22:16 GMT
Approval Date
Reference Listed Drug
Generic Drug Name
NDA Holder
…
Endari
L-Glutamine
Emmaus Medical
Novitium Pharma
215647
07… #47;29/2024
Cubicin
Daptomycin
Cubist
Biocon Pharma
… 2024
Tarceva
Erlotinib HCl
OSI Pharmaceuticals
Hikma
203843
09…
-
Human medicines European public assessment report (EPAR): Cubicin, daptomycin, Date of authorisation: 19/01/2006, Revision: 38, Status: Authorised
20 Jun 2024 19:02 GMT
… most common side effects with Cubicin (which may affect between 1 … pneumonia (infection of the lungs), drug rash with eosinophilia and systemic … side effects and restrictions of Cubicin, see the package leaflet.
-
Which ASX companies are resurrecting abandoned drugs? Part 1
15 Apr 2024 12:50 GMT
… the drug.
“Many small biotechs and … pre-treatment
In some trials, clinical … Cubicin (daptomycin) was successfully repurposed by Cubist Pharmaceuticals after pharmaceutical … drug receiving FDA approval for a human indication.
“NASDAQ-listed Tarsus Pharmaceuticals …
-
Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act
13 Sep 2023 02:34 GMT
… /30/14)
The Medicines Company
Cleviprex (clevidipine) IV emulsion … )*
Egalet US, Inc. (formerly Luitpold Pharmaceuticals, Inc.)
Sprix (ketorolac tromethamine) Nasal … )*
Merck Sharpe & Dohme Corp.
Cubicin (daptomycin for injection) 500 mg …
-
Everest Medicines' Xerava receives Taiwan FDA approval to treat complicated intra─abdominal infections in adult patients
29 Sep 2023 05:55 GMT
… New Drug Application (NDA) for Xerava (eravacycline) for the treatment … +sulbactam), Colistin (colimycin) and Cubicin (daptomycin).
Xerava (eravacycline) is … transformative pharmaceutical products and vaccines that address critical unmet medical needs …
-
Everest Medicines Announces Approval of XERAVA® in Taiwan for the Treatment of Complicated Intra-Abdominal Infections in Adult Patients
28 Sep 2023 01:11 GMT
… Drug Application (NDA) for XERAVA® (eravacycline) for the treatment … +sulbactam), Colistin (colimycin) and Cubicin (daptomycin).
About XERAVA® (eravacycline … transformative pharmaceutical products and vaccines that address critical unmet medical needs …
-
Acute Bacterial Skin and Skin Structure Infections Market to Grow Substantially by 2032, Assesses DelveInsight | Key Companies - Melinta, AbbVie, Basilea, Motif Bio, Cubist, Paratek, Durata, The Medicine Company
23 Aug 2023 17:00 GMT
… about ABSSSI treatment, visit @ ABSSSI Treatment Drugs Key … Medicine Company
Tygacil (Tigecycline): Weyth Pharmaceutical
Cubicin (Daptomycin): Cubist Pharmaceutical
… the FDA-approved drugs for ABSSSI @ Drugs for … drugs in development @ ABSSSI Clinical Trials …
-
Taiwan FDA accepts Everest Medicines' NDA for Xerava to treat complicated intra─abdominal infections
12 Aug 2022 11:26 GMT
… (colimycin) and Cubicin (daptomycin).
“The acceptance of our New Drug Application for … , chief executive officer of Everest Medicines. “With a robust organization that … La Jolla Pharmaceutical Company). Xerava was approved for the treatment of cIAI …
-
Dermatological Drugs Market Report Up to 2031, By Visiongain Research Inc
27 Dec 2021 12:48 GMT
… Taltz, Otezla), by Dermatitis Drugs (Cubicin, Zyvox, Valtrex, Canesten, … skin treatments. The players in the dermatological drugs … Pharmaceutical Industries Limited
Sanofi Pasteur Pharmaceutical
Takeda Pharmaceutical Company Limited
Taro Pharmaceutical …
About
© 1995-2025