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:10/13/2017)... Fort Worth, TX (PRWEB) , ... October 13, ... ... and financial planning agency serving communities in the greater Dallas, Miami, and Raleigh ... a young boy fighting to overcome a rare and deadly chromosome abnormality. , ...
(Date:10/13/2017)... ... October 13, 2017 , ... While it’s often important to ... Fortunately, an inventor from Austin, Texas, has identified a solution. , She developed a ... or restricted lighting. As such, it eliminates the need to turn on a light ...
(Date:10/13/2017)... ... October 13, 2017 , ... PurhealthRX , a leading Health ... technology. Applying the Purzorb™process to full spectrum CBD oil will revolutionize the rapidly growing ... form that can be easily incorporated into liquid products, while reducing costs to end ...
(Date:10/13/2017)... ... October 13, 2017 , ... Apple Rehab Shelton Lakes , which specializes ... of the facility as part of a disaster drill on October 3rd. , Apple ... Shelton City Emergency Manager, as well as the Connecticut Long Term Care Mutual ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network ... advocate for action towards gender equality at their inaugural Summit in New York City ... and reached a social audience of over 3 million. To watch the Mobilize Women ...
Breaking Medicine News(10 mins):
(Date:9/25/2017)... , Sept. 25, 2017   Montrium ... Master File solutions, today—from the IQPC Trial Master ... , NL)—announced that EastHORN Clinical Services has ... clinical programs and TMF management. EastHORN, a leading ... eTMF platform to increase transparency to enable greater ...
(Date:9/22/2017)... AVACEN Medical (AVACEN) announced that its CE-Marked ... those with the widespread pain associated with fibromyalgia in ... Essex, England commented, "I had ... no sleep at all, tremendous pain, with every movement ... [the AVACEN 100] enough, how this has and is ...
(Date:9/18/2017)... R.I. , Sept. 18, 2017 /PRNewswire/ ... the fields of bioinformatics and immune engineering, ... a protective avian influenza A (H7N9) vaccine. ... distantly related to seasonal influenza and presents ... rely on prior exposure to be effective. ...
Breaking Medicine Technology: