Navigation Links
Mylan Receives Approval for Hydroxyzine Hydrochloride Tablets
Date:6/17/2010

PITTSBURGH, June 17 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Hydroxyzine Hydrochloride Tablets 10 mg, 25 mg and 50 mg. The product was determined to be bioequivalent and, therefore, therapeutically equivalent to Pliva's Hydroxyzine Hydrochloride Tablets, a treatment for nervousness and tension.  

Hydroxyzine Hydrochloride Tablets had U.S. sales of approximately $55 million for the 12 months ending March 31, 2010, according to IMS Health.

Currently, Mylan has 138 ANDAs pending FDA approval representing $95.2 billion in annual brand sales, according to IMS Health. Forty of these pending ANDAs are potential first-to-file opportunities, representing $21 billion in annual brand sales, for the 12 months ending Dec. 31, 2009 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 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, please visit www.mylan.com.


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

Related medicine technology :

1. Mylan Announces Settlement Agreement Related to Antidepressant Effexor XR(R)
2. Mylan Receives FDA Approval for Generic Version of Parkinsons Treatment Sinemet(R)
3. Mylan Schedules Third Quarter 2009 Financial Results Conference Call and Live Webcast
4. Mylan Receives FDA Approval for Generic Version of Anticonvulsant Topamax(R) Sprinkle Capsules
5. Mylan Confirms First-to-File Patent Challenge Relating to Caduet(R)
6. Mylan Receives Approval for Generic Version of GoLytely(R)
7. Mylan Declares Quarterly Preferred Stock Dividend
8. Mylan Pre-Pays All Scheduled 2011 Term-Loan Borrowings
9. Mylan Confirms First-to-File Patent Challenge Relating to Vytorin(R) Cholesterol Medication
10. Mylans President of Europe, Middle East and Africa Elected President of European Generic Medicines Association
11. Mylan Receives Tentative FDA Approval Under PEPFAR for Matrix Laboratories New Drug Application (NDA) for Efavirenz Tablets
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/9/2016)... Research and Markets has announced the addition of the ... ... vaccines market to grow at a CAGR of 6.83% during the ... the growth prospects of the global travel vaccines market for 2016-2020. ... from the sales of various vaccines administered to actively immunize meningococcal ...
(Date:12/8/2016)... IRIDEX Corporation (NASDAQ: IRIX ) today ... common stock, $0.01 par value (the "Offering" with such shares ... final terms of the Offering will depend on market and ... be no assurance as to whether or when the Offering ... net proceeds it will receive from this offering for working ...
(Date:12/8/2016)... , Dec. 8, 2016  The global biosurgery ... 8.8% during the forecast period of 2016 to 2021. ... by 2021 from USD 18.21 billion in 2016. The ... rising incidences of sports related injuries and spinal problems, ... rising need of effective blood loss management. ...
Breaking Medicine Technology:
(Date:12/9/2016)... , ... December 09, 2016 , ... ... at The Pierre Hotel in New York, NY, on December 3rd, to benefit ... and physicians attended the annual event, which raised over $1 million - the ...
(Date:12/8/2016)... ... December 08, 2016 , ... The Florida Hospital Tampa Wound ... Medical Society (UHMS), the leading authority in hyperbaric medicine. This accreditation identifies the ... hospitals and facilities have earned this distinction. This is the second time the ...
(Date:12/8/2016)... ... December 08, 2016 , ... ... Management (MTM), adherence, and other pharmacist-delivered patient care services, has announced the promotions ... Eric Hoessel to vice president of sales. , Litsinger joined Mirixa in ...
(Date:12/8/2016)... ... December 08, 2016 , ... ... access for customers and employees that are both engaging and easy to use. ... Smart Technology, the software company revealed today its plans to roll out new ...
(Date:12/8/2016)... ... December 08, 2016 , ... California Senate Bill (SB) 863, signed into law ... in 2013 and 2014, according to CompScope™ Medical Benchmarks for California, 17th Edition ... to the study, medical payments per claim in California decreased 4 percent in 2013 ...
Breaking Medicine News(10 mins):