Navigation Links
Mylan Receives Approval for Fludarabine Phosphate Injection, USP
Date:10/4/2010

PITTSBURGH, Oct. 4 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Bioniche Pharma received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fludarabine Phosphate Injection USP, 25 mg/mL, packaged in 50 mg/2 mL Single-dose Vials. The product was determined to be bioequivalent and, therefore, therapeutically equivalent to Teva Parenteral's Fludarabine Phosphate Injection USP, 25 mg/mL, a chemotherapy medication for B-cell chronic lymphocytic leukemia (CLL).  

Fludarabine Phosphate Injection USP, 25 mg/mL had U.S. sales of approximately $15 million for the 12 months ending June 30, 2010, according to IMS Health.

Bioniche Pharma is part of Mylan Institutional, a newly created platform that provides differentiated pharmaceutical products to institutional customers throughout North America. Mylan Institutional's product offering includes the specialty injectables of Bioniche Pharma with the unit dose capabilities of Mylan's UDL Laboratories. Mylan Institutional's customers include group purchasing organizations, wholesalers, hospitals, surgical and radiology services, home infusion service providers, long-term care facilities, correctional facilities, specialty pharmacies, veterinary clinics and retail outlets.

Currently, Mylan has 150 ANDAs pending FDA approval representing $94.2 billion in annual sales, according to IMS Health. Forty-two of these pending ANDAs are potential first-to-file opportunities, representing $21.9 billion in annual brand sales, for the 12 months ending June 30, 2010, according to IMS Health.

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories. The company maintains one of the industry's broadest and high
'/>"/>

SOURCE Mylan Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. Mylan Launches Generic Version of Wellbutrin XL® Tablets
2. Mylan Granted Temporary Restraining Order Against GlaxoSmithKline and Apotex Prohibiting the Supply, Sale and/or Importing of a Generic Version of Paxil CR
3. Mylan Receives Approval for Generic Version of Prograf® Capsules
4. Mylan Completes Acquisition of Bioniche Pharma Sooner Than Expected
5. Mylan Announces Completion of Add-On Offering of Senior Notes
6. Mylan Announces Pricing of Add-On Offering of Senior Notes
7. Mylan Launches the Generic Version of Solodyn®, 45 mg, 90 mg and 135 mg Tablets, Announces Settlement Agreement with Medicis
8. Mylan Announces Settlement Agreement for Namenda®
9. Mylan to Acquire Bioniche Pharma Global Injectable Pharmaceuticals Business
10. RoundTable Healthcare Partners Announces Sale of Bioniche Pharma Holdings Limited to Mylan Inc.
11. Mylan Receives Approval for Nabumetone Tablets
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/11/2014)... Fla. , July 11, 2014  Rock Creek ... biotechnology company, today announced that the Food and Drug ... will provide comments on RCP,s Investigational New Drug ("IND") ... clinical trial in the US. Dr. ... agency,s review and comments on our IND. When we ...
(Date:7/11/2014)... Australia , July 11, 2014  Australian drug ... announced that it has raised A$19.3 million via a ... Europe , the U.S., Asia ... A$3 million from a share purchase plan (SPP) to ... million will be made in two tranches. ...
(Date:7/11/2014)... Show organisers report ... Expo 2014 were a brand new audience ... London , plus a 10% increase ...      (Logo: http://photos.prnewswire.com/prnh/20130723/629764-a) ...      (Photo: http://photos.prnewswire.com/prnh/20140711/696892-b ) ...
Breaking Medicine Technology:Rock Creek Pharmaceuticals Issues Update On US Investigational New Drug Application 2Phosphagenics' A$19.3 million Capital Raising 2Phosphagenics' A$19.3 million Capital Raising 3UK's Flagship Health & Safety Event Has Successful Inaugural Year in London 2UK's Flagship Health & Safety Event Has Successful Inaugural Year in London 3UK's Flagship Health & Safety Event Has Successful Inaugural Year in London 4
(Date:7/14/2014)... (PRWEB) July 14, 2014 Top nutritional ... expansion of its Quality Control and Assurance Department. As ... hired two additional, highly-qualified quality assurance (QA) and quality ... standards for which IQ Formulations has become known. ... technicians bring decades of stellar experience and qualifications to ...
(Date:7/14/2014)... BCC Research ( http://www.bccresearch.com ) ... GLOBAL MARKETS , the global synthetic biology market ... in 2018, with a five-year compound annual growth ... the fastest growing segment, with anticipated $9.7 billion ... in the pharmaceutical/diagnostics, chemical, energy, and agricultural industries ...
(Date:7/14/2014)... 13, 2014 (HealthDay News) -- Along with improving vision, ... Alzheimer,s disease and other types of dementia, a new ... of life, the researchers said. "These preliminary results ... benefits for people with dementia and their loved ones, ... Case Western Reserve University and University Hospitals Case Medical ...
(Date:7/14/2014)... 2014 (HealthDay News) -- Stress can slow a woman,s metabolism ... study included 58 women, average age 53, who were asked ... a meal than included 930 calories and 60 grams of ... took the women to burn off those calories and fat. ... events during the previous 24 hours burned 104 fewer calories ...
(Date:7/14/2014)... Skin M.D. by The ... Monday, July 14th, located at 45 East Putnam ... all week through Saturday, July 19th, with free ... to attend. The business is owned by Karen ... weight loss services, and sells high-end industry leading ...
Breaking Medicine News(10 mins):Health News:Leading Health Supplement Company IQ Formulations Expands Quality Control and Assurance Department 2Health News:Global Market for Synthetic Biology to Reach Nearly $11.9 Billion by 2018 — Enabled Products Account for the Fastest Growing Segment with 36.7% CAGR 2Health News:Global Market for Synthetic Biology to Reach Nearly $11.9 Billion by 2018 — Enabled Products Account for the Fastest Growing Segment with 36.7% CAGR 3Health News:Cataract Surgery a Plus for Someone With Dementia, Study Says 2Health News:Stress May Leave You Heading to the Cookie Jar 2Health News:The Cosmetic Medic Announces Grand Opening of New Skin M.D., a Physician-Administered Anti-aging, Skincare, and Weight Loss Practice 2Health News:The Cosmetic Medic Announces Grand Opening of New Skin M.D., a Physician-Administered Anti-aging, Skincare, and Weight Loss Practice 3
... ... News reports that detainees being held by US forces at an undisclosed second detention ... temperature manipulation, and sleep deprivation. , ... Cambridge, MA (Vocus) -- Physicians for Human Rights (PHR) today called ...
... protective, experts say, , TUESDAY, May 11 (HealthDay News) -- ... offer the same protection against falls and fractures in older ... has found. , What,s more, the research suggests that when ... it actually increases the risk of falls by 15 percent ...
... As the United States moves toward the goal of a ... the Regenstrief Institute provides a framework for evaluating the costs, ... the health internet. The study, which appears in ... Medical Informatics Association , also reports on the initial assessment ...
... ... than serially, to deliver highly responsive, customer-oriented presentations. , ... London, UK (PRWEB) May 11, ... now available for Microsoft® Office PowerPoint®. This new software enables PowerPoint authors ...
... African Americans, colorectal cancer is the third most common cause ... a 90 percent cure rate, yet screening rates are much ... researchers have tried to figure out why, but most have ... haven,t explored the differences in what keeps African American men ...
... ... Take Championship Title , ... -- Human Touch ®, the U.S. market leader of innovative massage chairs, Perfect Chair® ... Pro Tim Clark for his first PGA TOUR victory in his career at one ...
Cached Medicine News:Health News:President Obama Must Investigate Reports of Detainee Abuse at Bagram Air Base 2Health News:Once-A-Year Vitamin D Megadose Ups Fracture Risk: Study 2Health News:Once-A-Year Vitamin D Megadose Ups Fracture Risk: Study 3Health News:Measuring success: Regenstrief helps assess value of investment in health info tech 2Health News:GMARK Launches World's First Web-Like, PowerPoint Navigation Software 2Health News:Exploring gender differences in colorectal cancer screenings 2Health News:Human Touch Brand Ambassador and PGA Pro Tim Clark Wins First PGA TOUR Victory at PLAYERS Championship 2Health News:Human Touch Brand Ambassador and PGA Pro Tim Clark Wins First PGA TOUR Victory at PLAYERS Championship 3
PhenoPath Laboratories provides screening, diagnostic, and prognostic testing services to hospitals, physician offices, surgery centers, biopharmaceutical companies and research institutions nationwi...
the LabOne Healthcare Group markets laboratory testing to physicians, patients, managed care companies, self-insured employers, wellness companies and hospitals....
... hemostatic gauze for a variety of inpatient and ... is easy to handle and can be customized ... that are often a challenge faced by obstetricians ... to control bleeding in outpatient procedures such as ...
Sharp tipped straight scissors. For cutting in the iris plane or cutting peripheral membranes. May also be useful in ROP cases....
Medicine Products: