Le Lézard
Classified in: Health, Science and technology
Subject: FDA

Abon Received Approval from the US FDA for Clofarabine Injection


NORTHVALE, N.J., May 16, 2017 /PRNewswire/ -- Abon Pharmaceuticals, LLC, a specialty pharmaceutical company, today announced that it has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for Clofarabine Injection, 20 mg/20 mL, Single-use Vial. Clofarabine Injection is a generic equivalent of Genzyme's CLOLAR® Injection, a prescription medicine indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. According to IMS data, the sales for CLOLAR® in 2016 were $67 M. Abon has entered into a distribution agreement with Fresenius Kabi USA to launch the product as First-to-Market generic for CLOLAR®. "This product launch is a significant milestone for Abon" said Salah U. Ahmed, PhD President and CEO of Abon Pharmaceuticals, an independent privately owned LLC.

About Abon Pharmaceuticals, LLC.
Abon Pharmaceuticals, LLC is a specialty pharmaceutical company that emphasizes science and technology in the development of generic and proprietary products with high formulation barriers. Abon has filed multiple patent applications for drug delivery technologies. To date, six products developed at Abon, have been filed with FDA. This is the third FDA approval of product developed by Abon team and the first approval of an Abon ANDA product.

Contact: Salah Ahmed, 845-304-3493, [email protected]

SOURCE Abon Pharmaceuticals, LLC


These press releases may also interest you

at 01:35
Regulatory News: Sensorion (FR0012596468 ? ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, today announces...

at 00:39
World Malaria Day is marked each year on April 25. World Health Organization (WHO) gave as the theme for World Malaria Day 2024 Accelerating the fight against malaria for a more equitable world. WHO stated that malaria not only continues to directly...

25 avr 2024
The report titled "Anti-Adhesion Products Market by Product Type (Natural Adhesion Barriers, Synthetic Adhesion Barriers), Product Form (Film Formulation, Gel Formulation, Liquid Formulation), Application, End-User - Global Forecast 2024-2030" is now...

25 avr 2024
Product: Meat and vegetable products Issue: Food - Microbial Contamination - Listeria Distribution:British Columbia See the affected products and product photos for this recall SOURCE Canadian Food Inspection Agency (CFIA)

25 avr 2024
The report titled "Contract Research Organization Services Market by Type (Clinical Research Services, Consulting Services, Data Management Services), Trial Phase (Phase I, Phase II, Phase III), Therapeutic Area, Molecule Type, End-User - Global...

25 avr 2024
Greenbrook TMS Inc. ("Greenbrook" or the "Company") today announced its fiscal year ended December 31, 2023 ("Fiscal 2023") operational and financial results. All values in this news release are in United States dollars, unless otherwise stated....



News published on and distributed by: