Navigation Links
Mylan One of First to Launch Generic Version of Boniva®
Date:3/20/2012

PITTSBURGH, March 20, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Ibandronate Sodium Tablets, 150mg. This product is the generic version of Roche's Boniva®, which is indicated for the treatment and prevention of osteoporosis in postmenopausal women.

Boniva® had U.S. sales of approximately $517 million for the 12 months ending Dec. 31, 2011, according to IMS Health. Mylan is shipping the product immediately.

Currently, Mylan has 173 ANDAs pending FDA approval representing $100.9 billion in annual sales, according to IMS Health. Forty-two of these pending ANDAs are potential first-to-file opportunities, representing $27.4 billion in annual brand sales, for the 12 months ending December 31, 2011, 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 150 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information about Mylan, please visit www.mylan.com. For more information about generic drugs, please visit www.ChoosingGenerics.com.


'/>"/>
SOURCE Mylan Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1

Related medicine technology :

1. Mylan Canada Receives Health Canada Approval for Generic Version of Crestor®
2. Mylan Continues to Pursue Damages and Injunction Against Sunovions Brovana® in Ongoing Litigation
3. Mylan Pharmaceuticals President Tony Mauro Elected Chairman of GPhA
4. Mylan Secures an Additional $300 Million of Committed Financing
5. Mylan Reports Adjusted Diluted EPS of $0.53 for the Quarter, an 18% Increase Over Prior Year Quarter; and $2.04 for the Year, a 27% Increase Over Prior Year
6. Mylan and Pfizer Announce Epinephrine Auto-injector Settlement Agreement
7. Mylan to Change Name of Specialty Subsidiary From Dey Pharma to Mylan Specialty
8. Mylan Actively Addressing Shortage of Preservative-Free Methotrexate Injection
9. Mylan CEO Heather Bresch Testifies Before Congress in Support of Generic Drug User Fee Program and Urges Update of Federal Food, Drug and Cosmetic Act of 1938 to Create a Level Playing Field for Manufacturers
10. Mylan Completes Acquisition of Two Limited-Competition Dermatological Products from Valeant
11. Valeant Pharmaceuticals Completes Divestiture of Generic Dermatology Products to Mylan
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/5/2017)... -- Sapheneia and Scannerside received FDA 510(k) clearance to ... third-party Vendor neutral CT product that makes it affordable ... current MITA standards. ... specifically designed to provide CT operators, prior to a ... a predefined threshold. Scannerside Dose Check is intended to ...
(Date:9/5/2017)... , Sept. 5, 2017  Getinge, a ... created a vibrant charitable donation program -- "Color ... support congenital heart defect research by The Children,s ... and the general public are encouraged to download ... submit the completed artwork to the gallery on ...
(Date:9/5/2017)... 2017 Oramed Pharmaceuticals Inc. (NASDAQ: ... pharmaceutical company focused on the development of oral drug ... its meeting with the U.S. Food and Drug Administration ... At the meeting, ... for submission of ORMD-0801, would be a Biologics License ...
Breaking Medicine Technology:
(Date:9/22/2017)... (PRWEB) , ... September 22, 2017 , ... ... preserve fertility and create life. Although frozen embryos have a slight statistical advantage ... , “Egg freezing is a wonderful opportunity for women undergoing medical treatment or ...
(Date:9/21/2017)... Aliso Viejo, CA (PRWEB) , ... September 21, 2017 , ... ... never been so fun and easy to do. Users can select from up to ... more all with a click of a mouse all within Final Cut Pro ...
(Date:9/21/2017)... (PRWEB) , ... September 21, 2017 , ... ... Sept. 26, 2017 — 1:30 p.m. – 3:00 p.m. ET, http://www.fdanews.com/processcapabilityindices      ... easy to get things wrong, run afoul of The Quality System Regulation (§820.250), ...
(Date:9/21/2017)... ... September 21, 2017 , ... ... Infinity Behavioral Health Services for professionals in the addiction treatment industry entitled: ... . , Insurance companies and state and federal governments are increasingly scrutinizing ...
(Date:9/21/2017)... IL. (PRWEB) , ... September 21, 2017 , ... ... results released today of a new member survey conducted by the International ... restoration procedures performed from 2014 to 2016 rose 60 percent, with 635,189 procedures ...
Breaking Medicine News(10 mins):