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:5/25/2016)... MedDay, a biotechnology company focused on the treatment ... "High doses of biotin in progressive multiple sclerosis: extension phase ... Ayman Tourbah , Principal Investigator of the Phase 3 ... Neurology (EAN) in Copenhagen, Denmark . The ... on Sunday, 29 May 2016 from 14:45 to 16:15 CEST ...
(Date:5/24/2016)... --   , ... Endpunkte und demonstriert Ebenbürtigkeit bei der Gesamtreinigung des ... guter , Reinigung des ... (Logo: http://photos.prnewswire.com/prnh/20130829/633895-a ) , ... der MORA-Studie der Phase III für NER1006 (1 ...
(Date:5/24/2016)... Celsion Corporation (NASDAQ: CLSN ... an update on its ongoing OVATION study, a ... the Company,s DNA-based immunotherapy, with the standard of ... advanced ovarian cancer who will undergo neoadjuvant chemotherapy ... IL-12 DNA plasmid vector formulated as a nanoparticle ...
Breaking Medicine Technology:
(Date:5/27/2016)... ... 27, 2016 , ... More than a third of American adults are considered ... surgery has received increased attention in recent years, as an article published ... weight loss, most people are familiar with the basic requirements of maintaining a healthy ...
(Date:5/27/2016)... ... ... With over 60 percent of acute stroke survivors being left unable to ... in the rehabilitation process has steadily increased. Ekso Bionics had been working to help ... stroke. , Ekso Bionics has now received clearance from the U.S. Food and Drug ...
(Date:5/27/2016)... ... May 27, 2016 , ... Aimed ... by inspiring human interest stories, courtesy of leaders in the nursing and health ... the industry, from leading advocates and associations—namely Jones & Bartlett Learning. , Jones ...
(Date:5/26/2016)... ... ... There are many ways to cook a hot dog, but new research commissioned ... dogs straight off the grill. Of the 90 percent of Americans who say they ... hot dog, far outpacing other cooking methods such as steaming (12 percent), microwaving (9 ...
(Date:5/26/2016)... , ... May 26, 2016 , ... Connor Sports, ... basketball as a partner for the Tamika Catchings Legacy Tour that will ... industry leader in hardwood basketball surfaces in all forms and levels of the game, ...
Breaking Medicine News(10 mins):