Navigation Links
Mylan Receives FDA Approval for Generic Version of Anticonvulsant Topamax(R) Sprinkle Capsules
Date:10/15/2009

PITTSBURGH, Oct. 15 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Topiramate Capsules (Sprinkle), 15 mg and 25 mg.

Topiramate Capsules (Sprinkle) are the generic version of Ortho McNeil's anticonvulsant Topamax® Sprinkle Capsules, 15 mg and 25 mg. For the 12 months ending June 30, 2009, Topiramate Capsules (Sprinkle) had U.S. sales of approximately $58 million for the same strengths, according to IMS Health. Mylan has launched this product.

Currently, Mylan has 121 ANDAs pending FDA approval representing $85.7 billion in annual brand sales, according to IMS Health. Thirty-four of these pending ANDAs are potential first-to-file opportunities, representing $17.9 billion in annual brand sales, 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 highest quality product portfolios supported by a robust product pipeline; operates the world's third largest active pharmaceutical ingredient manufacturer; and runs a specialty business focused on respiratory and allergy therapies. For more information, please visit www.mylan.com.

SOURCE Mylan Inc.


'/>"/>
SOURCE Mylan Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1

Related medicine technology :

1. Mylan Schedules Third Quarter 2009 Financial Results Conference Call and Live Webcast
2. Mylan Receives FDA Approval for Generic Version of Parkinsons Treatment Sinemet(R)
3. AbbeyMoor Medical Receives Category I CPT(R) Code for The Spanner(TM) Prostatic Stent Procedure
4. Ortho Clinical Diagnostics Receives FDA Approval for First Anti-HIV 1+2 Test for Use on Random Access, Integrated Laboratory Testing System
5. Prime Therapeutics Receives 2010 TIPPS Certification for Adherence to High Transparency Standards
6. VIA Pharmaceuticals Receives Favorable Hearing Decision From NASDAQ
7. Otix Global Receives Nasdaq Bid Price Notice Deficiency
8. CVS/pharmacys Transportation Operations Receives Two National Safety Awards
9. Biostar Pharmaceuticals, Inc. Receives the Chinese Military Drug Administration Clearance to Begin Clinical Trial for Zushima Analgesic Aerosol Spray
10. Stereotaxis Receives Commitment to Increase and Extend Its Credit Facility With Silicon Valley Bank
11. SIMPONI(TM) (golimumab) Receives European Approval as Once-Monthly Subcutaneous Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis with Novel SmartJect(TM) Autoinjector
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... LEXINGTON, Mass. , Dec. 23, 2014 /PRNewswire/ ... GEVA ), a biopharmaceutical company developing therapeutic products ... European Medicines Agency (EMA) of the Marketing Authorization ... The EMA recently granted the company,s request for ... the EMA,s regulatory review time.   ...
(Date:12/24/2014)... 2014  Lockton Dunning Benefits, the ... the addition of Vice President Kim Foerster ... Pharmacy Consulting team, Excelsior Solutions. ... to the position.  Most recently, she worked as ... Specialty Pharmacy, where she has held various managerial ...
(Date:12/24/2014)... 23, 2014 Tianyin Pharmaceutical Co., Inc. ... in patented biopharmaceutical, modernized traditional Chinese medicine (mTCM), ... announced that the Company achieved the Public Notice ... (GMP) certificate of TPI,s Qionglai Facility (QLF) from ... public notice period is a significant procedure of ...
Breaking Medicine Technology:Synageva BioPharma Announces Sebelipase Alfa Marketing Authorization Application Validated By The EMA 2Synageva BioPharma Announces Sebelipase Alfa Marketing Authorization Application Validated By The EMA 3Kim Foerster Joins Lockton Companies 2TPI QLF Achieved Public Notice Status of GMP Certification 2TPI QLF Achieved Public Notice Status of GMP Certification 3
(Date:12/25/2014)... Recently, Dylan Queen, a famous online company supplying women’s ... discounted prom dresses, most of which are priced under ... company, the promotion is valid until Jan. 22, 2015; ... UK market. , The prom dresses in this new ... A-line strapless, empire strapless chiffon, one shoulder, floor-length, V-neck ...
(Date:12/25/2014)... California (PRWEB) December 25, 2014 Helen ... home in Woodland Hills, California after an 8 year ... away on Christmas Eve evening in her home in ... aggressive metastatic breast cancer. , As ... over forty years, she pioneered and championed many of ...
(Date:12/25/2014)... THURSDAY, Dec. 25, 2014 (HealthDay News) -- The risk ... the holidays, so you need to be extra cautious, ... Day, we see a significant increase in patients coming ... at the Suffolk County Volunteer Firefighters Burn Center of ... celebrations should be full of joy, but if not ...
(Date:12/25/2014)... AngelWeddingDress.com tries its best to translate ... Today, the business has introduced its new collection of ... promotion. , The new prom outfits are guaranteed to ... lover. They are specially designed for 2015. Anyone who ... should visit its website before Jan. 26, 2015, the ...
(Date:12/25/2014)... 2014 Residents at Abernethy ... showed their generous spirit by providing holiday gifts ... Parenting Network- Grandparents Raising Grandchildren program. , Following ... the largest Christmas tree on the campus of ... residents of the Abernethy Village Association (AVA). Each ...
Breaking Medicine News(10 mins):Health News:Dylan Queen: Cheap Prom Dresses for the UK Market 2Health News:RP International founder, Helen Harris Dies on Christmas Eve Just Hours Before Her Holiday Television Broadcast to Raise Funds to Cure Blindness was Broadcasted Nationally 2Health News:RP International founder, Helen Harris Dies on Christmas Eve Just Hours Before Her Holiday Television Broadcast to Raise Funds to Cure Blindness was Broadcasted Nationally 3Health News:RP International founder, Helen Harris Dies on Christmas Eve Just Hours Before Her Holiday Television Broadcast to Raise Funds to Cure Blindness was Broadcasted Nationally 4Health News:Don't Let Burns Mar Your Holidays 2Health News:Angelweddingdress 2015 Prom Dresses Online Now 2Health News:Retirement Community Residents Make Impact During Holiday Season 2
... February is Heart ... … while having fun, too. , ... Los Angeles (Vocus) January 25, 2010 -- Every year, over 40,000 American women die ... to be one of them! , , , , ,February is Heart Health Month. Self-care ...
... ... hablan de disparidades e instan a los grupos de socorro a que tengan en ... ... del pasado indica que probablemente las mujeres y los niños en Haití no estén ...
... Center at the University of California, San Diego and ... between county hospitals and private providers. Patients treated in ... patients treated in private facilities tend to receive radiation ... the journal Cancer on January 25. ...
... Children who are mixed-handed, or ambidextrous, are more likely ... childhood than right- or left-handed children, according to a ... . The researchers behind the study, from ... their findings may help teachers and health professionals to ...
... ... the Christian perspective, promote faith-formation. , ... (PRWEB) January 24, 2010 -- Witness to Hope Ministries, a nonprofit ... behavioral health practice in Beaver, PA in order to serve at-risk and special needs ...
... 24, 2010 When University of Utah scientists discovered a ... conducting plastic or polymer, no one could explain how it ... later, the Utah researchers have found these "random lasers" occur ... say such lasers may prove useful for diagnosing cancer. ...
Cached Medicine News:Health News:Save The Ta-Ta's ... And Your Ticker 2Health News:Save The Ta-Ta's ... And Your Ticker 3Health News:Estn las Mujeres y los Nios de Hait Recibiendo Menos Ayuda Tras el Terremoto? 2Health News:Estn las Mujeres y los Nios de Hait Recibiendo Menos Ayuda Tras el Terremoto? 3Health News:Estn las Mujeres y los Nios de Hait Recibiendo Menos Ayuda Tras el Terremoto? 4Health News:Study confirms prostate cancer is treated differently at county vs. private hospitals 2Health News:Mixed-handed children more likely to have mental health, language and scholastic problems 2Health News:Mixed-handed children more likely to have mental health, language and scholastic problems 3Health News:Christian Nonprofit and Behavioral Health Practice Team Up to Help Children 2Health News:How 'random' lasers work 2Health News:How 'random' lasers work 3Health News:How 'random' lasers work 4Health News:How 'random' lasers work 5
... flexible continuous monitoring, the M3 and M4 ... and neonatal patient care. M Series monitors ... includes a basic set of non-invasive parameters ... Optional Multi-Measurement Server extensions offer Mainstream or ...
... On-line Electronic Help (OLEH), an ... to critical anesthesia-related information. OLEH brings ... need it most right on ... care of the patient and ...
Compact networked patient monitors for flexible care....
... for flexible care settings., ,IntelliVue ... portability and measurement flexibility to match ... intermediate care environmentsat the patients side., ... in patient monitoring, IntelliVue has highly ...
Medicine Products: