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:2/4/2016)... 4, 2016  Omnicell, Inc. (NASDAQ: OMCL ), a ... healthcare systems, today announced results for its fiscal year ... --> --> GAAP results: Revenue for ... $5.1 million or 4.1% from the third quarter of ... fourth quarter of 2014. Revenue for the year ended ...
(Date:2/4/2016)... 2016  Aethlon Medical, Inc. (Nasdaq: AEMD ... to treat life-threatening diseases, today announced results for ... 31, 2015. --> ... in our last quarterly call, we strategically advanced ... objective to establish the Aethlon Hemopurifier® as a ...
(Date:2/4/2016)... 4, 2016  AMRI (NASDAQ:  AMRI) today announced that ... and President of Pfizer Global Supply, has been elected to ... 2016. In addition, the Company announced that Mr. Gabe ... since 2010, has retired from the AMRI Board of Directors ... other business ventures.  William S. Marth , ...
Breaking Medicine Technology:
(Date:2/7/2016)... Texas (PRWEB) , ... February 07, 2016 , ... ... new MyDecision™ program. MyDecision™ empowers employers and organizations with the tools and information ... MyDecision™ combines three elements to cut the cost of providing employee healthcare benefits ...
(Date:2/6/2016)... ... February 06, 2016 , ... ... ADVISORY: 5000 PERIOPERATIVE NURSES EXPECTED AT AORN SURGICAL CONFERENCE & EXPO , ... the world with an estimated 5000 perioperative nurses in attendance to study ...
(Date:2/6/2016)... ... ... With the FCPX LUT: Summer pack from Pixel Film Studios, ... is a Lookup Table that contains a mathematical formula for modifying an image. The ... manipulating each pixel, LUT's can change each color range differently, it gives the user ...
(Date:2/6/2016)... , ... February 06, 2016 , ... ... of eating disorder treatment helps to reduce the frequency and level of relapse. ... Recovery Phase: Re-Establishing Healthy Identity and Purpose,” will explore the critical tasks of ...
(Date:2/5/2016)... ... February 05, 2016 , ... Love is in the air ... variety of colors, assortments and packaging. This staple for Valentine’s Day is a must-have, ... , For Valentine’s Day, not only are long-stem roses available, but also other ...
Breaking Medicine News(10 mins):