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:12/4/2016)... Newport Beach, CA (PRWEB) , ... December 04, ... ... youthful appearance without undergoing major cosmetic surgery can now take advantage of a ... is an advanced skin rejuvenation treatment that reduces the appearance of age spots, ...
(Date:12/4/2016)... ... December 04, 2016 , ... Responsible dental care hinges on regular ... to achieve optimal results. This important necessity inspired an inventor from Las Vegas, Nev., ... to ensure that people break or avoid bad techniques of brushing the teeth in ...
(Date:12/2/2016)... ... December 02, 2016 , ... Lori G. Cohen and ... office, will speak at the American Conference Institute’s 21st Drug & Medical Device ... a Lead Sponsor of the conference. , Cohen, who chairs the firm’s Pharmaceutical, Medical ...
(Date:12/2/2016)... Calif. (PRWEB) , ... December 02, 2016 , ... On ... at the Hard Rock Hotel San Diego honoring the 2016 MPN Heroes—eight individuals who ... neoplasms (MPNs) by going above and beyond the standard of care, demonstrating leadership within ...
(Date:12/2/2016)... ... December 02, 2016 , ... ... Area in Alabama are expected to attend the UNCF Dothan-Wiregrass Mayor’s Luncheon Dec. ... scholarship funds for area students and operating support to UNCF-member institutions, including Miles ...
Breaking Medicine News(10 mins):
(Date:12/2/2016)... , December 2, 2016 Orthopedic ... & Support) is Expected to Gain a Significant Market Share ... Orthopedic Ailments  ... , According to a ... on Medical Implants Sterile Packaging: Clamshell Product Type Segment Projected ...
(Date:12/2/2016)... N.J. , Dec. 2, 2016   CytoSorbents ... immunotherapy leader commercializing its European Union approved CytoSorb ... and cardiac surgery patients worldwide, announced that Dr. ... the 9th Annual LD Micro Main Event ... , 2016 at the Luxe Sunset Boulevard Hotel in ...
(Date:12/2/2016)... , December 2, 2016 On Thursday, ... 1.36%; the Dow Jones Industrial Average edged 0.36% higher, to ... down 0.35%. Losses were broad based as six out of ... initiated research reports on the following Services equities: Myriad Genetics ... QGEN ), INC Research Holdings Inc. (NASDAQ: ...
Breaking Medicine Technology: