Navigation Links
Mylan Receives Approval for Hydroxyzine Hydrochloride Tablets

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

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:
(Date:10/12/2015)... Oct. 12, 2015  CME Group,s Center for Innovation ... CEO of Theranos, is the 11 th recipient of ... the revolutionary blood diagnostics company, Theranos , to change ... in a new era of preventive care. CME Group will ... Leadership Conference in Naples, Florida , ...
(Date:10/12/2015)... , October 12, 2015 ... - Pipeline Review, H2 2015 market research report ... R&D pipelines by identifying new targets and MOAs ... . --> ... pipeline spread across 62 pages, analyzing 6 companies, ...
(Date:10/12/2015)... VALLEY COTTAGE, New York , October 12, 2015 /PRNewswire/ ... Market Insights (FMI) delivers key insights on the global vital ... Signs Monitoring Devices Market: Global Industry Analysis and Opportunity Assessment ... to expand at a healthy CAGR of 9.5% and 9.2% ... period, due to factors, regarding which FMI offers major insights ...
Breaking Medicine Technology:
(Date:10/13/2015)... ... October 13, 2015 , ... ActivePDF, a ... PDF automation tool to batch conversions of CAD drawings, plans, and diagrams ... fidelity. , CADConverter eliminates the complexity requirement of specialized applications to view CAD ...
(Date:10/13/2015)... ... October 13, 2015 , ... ... the world’s first commercially-available next-generation sequencing laboratory test for bacterial vaginosis- a ... and Obstetrics in Vancouver, BC, Canada. , In a presentation entitled: ...
(Date:10/12/2015)... ... October 13, 2015 , ... ... biannual Heroes in Recovery Awards at Foundations Recovery Network’s Moments of Change conference ... the one-of-a-kind awards to Noah Levine and Dean Dauphinais who exemplify the ideals ...
(Date:10/12/2015)... CA (PRWEB) , ... October 12, 2015 , ... According to an article ... data from adults today versus those of a similar group taken in 1988 has shown ... that a person in 2008 with the same diet as someone in 1971 would be ...
(Date:10/12/2015)... ... October 12, 2015 , ... Amerec , a leader in ... and skin care equipment, will be displaying custom sauna and steam room solutions at ... high-end resorts and spas as customers, SpaEquip is recognized for their ability to assist ...
Breaking Medicine News(10 mins):