Navigation Links
Mylan Announces Tentative FDA Approval for Its ANDA

Mylan Laboratories Inc. today announced that Mylan Pharmaceuticals Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Paroxetine Hydrochloride Extended-release Tablets, 12.5 mg and 25 mg.

Mylan's ANDA is eligible to receive final approval on June 29, 2007, concurrent with the expiration of the pediatric exclusivity associated with U.S. patent 4,721,723.

Paroxetine Hydrochloride Extended-release Tablets are the generic version of GlaxoSmithKline's Paxil CR(R). Paroxetine Hydrochloride Extended-release Tablets had U.S. sales of approximately $307 million for the 12 months ending March 31, 2007, for the same strengths.

Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories Inc., and a controlling interest in Matrix Laboratories Limited, India. Mylan develops, licenses, manufactures, markets and distributes an extensive line of generic and proprietary products.


'"/>




Page: 1

Related medicine news :

1. Mylan Announces Final FDA Approval for Fluoxetine Capsules
2. Mylan Wins Its Amlodipine Case With Pfizer
3. Ramdoss Announces Introduction of RCH-II
4. Britain Announces Third Transfusion Related Mad Cow Case
5. Tibet Announces the Dalai Lama’s Tour of South Americ
6. Indian PM Announces Of Setting Up India Study Center At Tashkent
7. PowderMed Announces Needle-Less Flu Vaccine
8. Malaysia Announces Prison term On People Donating HIV-Contaminated Blood
9. Gates Foundation Announces $287 Million In Grants Towards AIDS Vaccine
10. Australian Government Announces Survey To Tackle Childhood Obesity
11. New Zealand Announces 10-year Plan For Betterment Of Mental Health Care
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:3/23/2017)... ... March 23, 2017 , ... After raising more than $1.135 million ($1,479,231 AUD) ... travel pillow in crowdfunding history, has established a U.S. Headquarters in New York ... to Americans. , “We’re excited to be operating on U.S. shores, where most of ...
(Date:3/23/2017)... ... 2017 , ... ?This conference will prominently feature 150+ Hospital and Health System Executive Speakers including: ... Salka , 43rd President of the United States of America: George W. Bush ... and Out of the Ring: Sugar Ray Leonard , JD, Chairperson, McGuireWoods LLP: ...
(Date:3/23/2017)... OR (PRWEB) , ... March 23, 2017 , ... Sharon ... Water, Global Climate Change and Your Health on VoiceAmerica, recently talked on her program ... she also used the occasion to remind listeners of an important distinction. World Water ...
(Date:3/23/2017)... ... March 23, 2017 , ... Natural Subsistence, a company ... people’s health and nutrition, announced its product Leyzene is now available for purchase ... nutritional supplements that help people improve all aspects of their health so they ...
(Date:3/23/2017)... ... 2017 , ... Inflow IQ & Inflownomics of Raleigh, NC introduce a powerful ... foundation. As experts in dangerous situations the Inflow IQ team can help people. ... ripe, fresh, clean & refreshing knowledge systems that enhance life. , Authentically ...
Breaking Medicine News(10 mins):
(Date:3/23/2017)... AVIV, Israel, March 23, 2017  Galmed Pharmaceuticals ... the "Company"), a clinical-stage biopharmaceutical company focused on ... the treatment of nonalcoholic steatohepatitis, or NASH, and ... the three and twelve months ended December 31, 2016, ... completed pre-clinical studies demonstrating Aramchol™,s potential direct effect ...
(Date:3/23/2017)... PUNE, India , March 23, 2017 ... 2022 report focuses on the Colposcope in Global market, especially in ... and Asia-Pacific , South America ... . This report categorizes the market based on manufacturers, regions, ... ...
(Date:3/23/2017)... SAN FRANCISCO , March 23, 2017 ... reach a value of USD 25.7 billion by 2025, according ... devices are expected to grow at a faster rate due ... to rising awareness about various types of esthetic procedures used ... from these disorders. Hence, they are considered as the highest ...
Breaking Medicine Technology: