Navigation Links
Mylan Receives Final FDA Approval for the Generic Version of the Antidepressant Sarafem(R) Pulvules(R) Capsules
Date:11/18/2008

PITTSBURGH, Nov. 18 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: 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 Fluoxetine Capsules USP, 10 mg and 20 mg.

Fluoxetine Capsules, indicated for the treatment of premenstrual dysphoric disorder (PMDD) are the generic version of Eli Lilly's Sarafem(R) Pulvules(R) Capsules. This product had annual U.S. sales of approximately $19.2 million for the 12 months ending Sept. 30, 2008, for the noted strengths, according to IMS Health. Shipment of the product will begin immediately.

Currently, Mylan has 112 ANDAs pending FDA approval, 23 of which are potential first-to-file opportunities.

Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest - and highest quality - product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's third largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies. For more information, please visit www.mylan.com.


'/>"/>
SOURCE Mylan Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1

Related medicine news :

1. Mylan Receives Final Approval for First-to-File Generic Version of Antiepileptic Keppra(R) and Launches Immediately
2. Mylan Declares Quarterly Preferred Stock Dividend
3. Mylans Matrix First-to-File on Generic Version of Vfend(R) Antifungal
4. Mylan to Retain Dey, L.P., Its Specialty Pharmaceutical Subsidiary
5. Mylan to Offer $400 Million in Cash Convertible Notes
6. Mylan Creates New Womens Health Care Franchise; Signs Agreement with Famy Care to Develop and Supply 22 Oral Contraceptive Products
7. Mylan Reports Adjusted Diluted EPS of $0.16 for the Quarter Ended June 30, 2008
8. Mylan Declares Quarterly Preferred Stock Dividend
9. Mylan Schedules Financial Results Conference Call and Live Webcast for the Second Quarter Fiscal 2008
10. Daniel E. Crookshank Joins Mylan as Vice President - Investor Relations
11. Mylan Announces Tentative FDA Approval for Generic Version of Antibiotic Zyvox(R) Tablets
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/20/2014)... 20, 2014 JZ Fitness, an independently ... corporate wellness programming, authorship, international lecturing and community wellness, ... announce the release of the JZ Fitness nutrition app, ... of coaching thousands of individuals on nutrition, Jenn Zerling ... does not require calorie counting or cumbersome food logging. ...
(Date:10/20/2014)... Myoderm announced today ... of their CentralSource service. Matthew will ... turnkey drug sourcing, distribution, and management service for ... years of industry experience, in both business development ... of their international success to help clients manage ...
(Date:10/20/2014)... National Teen Driver Safety Week is October 19-25, 2014 ... (Ohio AAP, http://www.ohioaap.org ) is joining the National Highway ... to talk to their teens and always set the rules ... the leading cause of death for U.S. teens. In 2012, ... 859 (42%) of those teen drivers were killed in crashes. ...
(Date:10/20/2014)... York, NY (PRWEB) October 20, 2014 ... be introduced in the U.S., has a lot to celebrate ... when our country recognizes the achievements and contributions of Americans ... the anniversary for Punzoné, and today it shares its favorite ... take a trip to Italy - even if it is ...
(Date:10/19/2014)... (PRWEB) October 20, 2014 The ... iPage ( http://www.top10bestseohosting.com/go/iPage/ ) and GreenGeeks are the ... excellent platforms for those who want to buy ... same time. , The IT manager of Top10BestSEOHosting.com ... the most recommended suppliers for everyone. A lot ...
Breaking Medicine News(10 mins):Health News:JZ Fitness Nutrition App Launches on iTunes 2Health News:JZ Fitness Nutrition App Launches on iTunes 3Health News:Myoderm Hires Matthew Voicheck to Lead Turnkey Drug Sourcing Service 2Health News:Ohio AAP Promotes National Teen Driver Safety Week 2Health News:Celebrate Italian Heritage Month With Authentic Cocktails from Punzoné: The Only Ultra Premium Line of Organic Imported Italian Vodka 2Health News:Celebrate Italian Heritage Month With Authentic Cocktails from Punzoné: The Only Ultra Premium Line of Organic Imported Italian Vodka 3Health News:Celebrate Italian Heritage Month With Authentic Cocktails from Punzoné: The Only Ultra Premium Line of Organic Imported Italian Vodka 4Health News:Top10BestSEOHosting.com Considers iPage And GreenGeeks As The Best Dedicated Server Hosting Suppliers 2
... Two researchers who translate math into,better patient care and one ... year,s winners of the Komen Brinker Award for Scientific,Distinction in ... in San Antonio, Susan G. Komen for the Cure(R) announced ... http://www.newscom.com/cgi-bin/prnh/20070122/NYM084LOGO ) , ...
... The U.S. Government, through the U.S. Agency for International Development ... cholera outbreak in Zimbabwe. This assistance is in addition ... USAID is already implementing in Zimbabwe. , ... alongside the international community to prepare for the possibility of ...
... An Ontario study of 491 women with invasive ovarian ... for genetic testing of BRCA1 and BRCA2, the breast ... of their cancer risk. , Dr. Kelly Metcalfe, ... S. Bloomberg Faculty of Nursing, and an adjunct scientist ...
... 4 NAMC members can gain access to cutting edge ... opportunities for interaction via computer. The next webinar will ... and Communicating With Your Online Audience , Do ... you,ve found them, do you know how to engage them? ...
... Healthcare, Inc. reminds,consumers to take full advantage of the ... expire by purchasing products to take,control of their personal ... nebulizers. , (Photo: ... (Photo: http://www.newscom.com/cgi-bin/prnh/20081204/AQTH541-b ) , ...
... Must Be Addressed , , ... incoming 111th Congress prepare for the many policy issues potentially ... American College of Surgeons (ACS) has released a comprehensive policy ... calls on policymakers to support a reform approach that improves ...
Cached Medicine News:Health News:Susan G. Komen for the Cure(R) Announces Recipients of 2008 Komen Brinker Award for Scientific Distinction 2Health News:USAID Increases Assistance for Zimbabwe Cholera Outbreak 2Health News:Few Ontario women with invasive ovarian cancer referred for genetic testing of breast cancer genes 2Health News:New NAMC Member Service! Complimentary Webinars for NAMC Members - On Topics You Need to Know! Sign Up Today for This New and Exciting Educational Program! 2Health News:Maximize Flex Spending Account Funds Before They Expire 2Health News:Maximize Flex Spending Account Funds Before They Expire 3Health News:American College of Surgeons Issues New Health Care Reform Agenda, Emphasizes Need to Address Access, Surgical Workforce Shortage 2Health News:American College of Surgeons Issues New Health Care Reform Agenda, Emphasizes Need to Address Access, Surgical Workforce Shortage 3Health News:American College of Surgeons Issues New Health Care Reform Agenda, Emphasizes Need to Address Access, Surgical Workforce Shortage 4
(Date:10/19/2014)... CTI BioPharma Corp. (CTI) (NASDAQ and MTA: ... quarter 2014 financial results on Wednesday, October 29, 2014, ... the announcement, members of the management team will host ... provide a general corporate update at 4:30 p.m. EDT ... obtained as follows: Wednesday, October 29 ...
(Date:10/19/2014)... Große Pharmafirmen werden oft ... dabei ist, dass große Pharmafirmen nicht willens sind, ... Es war deshalb nicht einfach, diesen ... mehr, dass es uns gelungen ist! Wir haben ... - mit einem Vorbehalt - einige haben uns ...
(Date:10/17/2014)... HILL, N.C. , Oct. 17, 2014 /PRNewswire/ ... landscape, the Medical Affairs function has come across ... allocating resources efficiently and managing globalization.  ... Best Practices, LLC is dedicated to providing benchmarking ... The Medical Affairs Consortium is a service composed ...
Breaking Medicine Technology:CTI BioPharma to Report Third Quarter 2014 Financial Results on October 29, 2014 2Vergleichsbericht zu Pharma-K├╝hlketten und CRT 2Early Key Findings from the Medical Affairs Consortium Research 2
A system for the removal and filtration of laser and surgical smoke....
Stryker Instruments, the leader in surgical helmets, offers its 4th generation of personal protection systems for todays surgical environment the Sterishield T4 System....
... The PS Medical Strata valve is ... the resistance properties of the valve can ... is designed to minimize overdrainage of cerebrospinal ... within a normal physiologic range, regardless of ...
... For faster test setup, try Cadwell paired ... reference discs. The custom-molded contacts are 10 ... made from solid stainless steel with a ... wires are color coded and available in ...
Medicine Products: