Navigation Links
Mylan Receives Final FDA Approval for the Generic Version of the Antidepressant Sarafem(R) Pulvules(R) Capsules

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

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:
(Date:11/30/2015)... , ... November 30, 2015 , ... According to Los ... people to overeat are not necessarily caused by real hunger, but instead by ... needs food. He notes that, while many patients are aware that weight loss surgery ...
(Date:11/30/2015)... (PRWEB) , ... November 30, 2015 , ... A record ... annual Regional Biotech Conference, organized by the Baruch S. Blumberg Institute. , The institute, ... of the area’s life science and biotechnology leaders for the conference, which focused on ...
(Date:11/30/2015)... ... 30, 2015 , ... A novel class of antimicrobials that ... in fighting methicillin-resistant Staphylococcus aureus (MRSA), one of the major drug-resistant bacterial pathogens, ... molecule analogs that target the functions of SecA, a central part of the ...
(Date:11/30/2015)... Scotch Plains, NJ (PRWEB) , ... November 30, ... ... is their top choice for innovative, patient centered orthopedic care. Led by ... Regardless of your injury or chronic condition, the team at Advocare Orthopedic & ...
(Date:11/30/2015)... (PRWEB) , ... November 30, 2015 , ... ... specializes in general dentistry out of Glen Ridge, NJ. He has both ... to achieve optimal mastication. He is also an expert in cosmetic dentistry. ...
Breaking Medicine News(10 mins):
(Date:11/30/2015)... November 30, 2015 North America ... expected to grow at a CAGR of 7.6% from 2015 to ... at USD 135.6 million in 2014, and is expected to grow ... According to the new Market Research Report "North America Cardiac ... End User (Hospitals, ambulatory care, others) - Analysis And Forecast To ...
(Date:11/30/2015)...  Kevin Smith has been appointed Chief Commercial ... in wireless monitoring of vital signs.  As CCO ... Mr. Smith will be responsible for the development ... will also directly oversee partnering with US hospitals ... SensiumVitals, the first early warning detection device to ...
(Date:11/30/2015)... SAN DIEGO , Nov. 30, 2015 ... ) today announced that the U.S. Food and Drug ... Application (NDA) for an extended release formulation of lorcaserin. ... a chronic weight management treatment in a once-daily dosing ... as an adjunct to a reduced-calorie diet and increased ...
Breaking Medicine Technology: