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:6/24/2016)... Michigan (PRWEB) , ... June 24, 2016 , ... June ... about the dangers associated with chronic pain and the benefits of holistic treatments, ... individuals who are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) is ...
(Date:6/24/2016)... ... , ... Comfort Keepers® of San Diego, CA is excited to announce they ... to drive cancer patients to and from their cancer treatments. Comfort Keepers provides ... life and ongoing independence. Getting to and from medical treatments is one of ...
(Date:6/24/2016)... Vegas, Nevada (PRWEB) , ... June 24, 2016 ... ... Las Vegas client, The Grove Investment Group (TGIG), has initiated cultivation and processing ... Grove, in Las Vegas and Pahrump, Nevada. , Puradigm is the manufacturer of ...
(Date:6/24/2016)... ... June 24, 2016 , ... Advanced Plastic ... Miss Arizona pageant as its official Medspa Sponsor. Dr. Josh Olson, a board-certified ... Arizona. , Dr. Olson says the decision to support the pageant in ...
(Date:6/24/2016)... ... ... SpiritQuest Sedona Retreats, located in Arizona has re-located to 75 Kallof Place, ... Rock, Airport Mesa, and Boynton Canyon. The new retreat center is ideally-situated ... the Sedona Rouge, both popular accommodations for SpiritQuest clients. The Medicine Wheel, Labyrinth ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... SAN CLEMENTE, Calif. , June 24, 2016  American Respiratory ... testing company, is now able to perform sophisticated lung assessments in ... Medical Technologies , Inc. Patients are no longer ... to ndd,s EasyOne PRO ® , ARL patients like Jeanne R. ... testing done in the comfort of her own home. ...
(Date:6/24/2016)... LEXINGTON, Mass. , June 24, 2016   ... specialty pharmaceutical company developing innovative inhaled drugs, announced today ... when Russell Investments reconstituted its comprehensive set ... 2016. "This is an important milestone for ... "It will increase shareholder awareness of our progress in ...
(Date:6/23/2016)... , June 23, 2016  MedSource announced ... as its e-clinical software solution of choice.  This ... best possible value to their clients by offering ... The preferred relationship establishes nowEDC as the EDC ... for MedSource,s full-service clients.  "nowEDC has long been ...
Breaking Medicine Technology: