FDa Drug Changes
Feb 19, 2012 12:49AM
Feb 16, 2012 05:20AM
Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for tafamidis meglumine, the company’s investigational, novel, oral therapy for the treatment of Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP).
Feb 14, 2012 09:08AM
Merck's Eye Medication Zioptan Approved
Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved Zioptan (tafluprost ophthalmic solution) 0.0015%, the first preservative-free prostaglandin analog ophthalmic solution.
Jan 31, 2012 12:50PM
FDA Approved New Type 2 Diabetes Drug
Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company today announced the U.S. Food and Drug Administration (FDA) has approved Jentadueto (linagliptin/metformin hydrochloride) tablets, a new tablet combining the dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin, and metformin.
Jan 30, 2012 03:36PM
Bydureon Approved for Type Two Diabetes
Some diabetes drugs have to be taken multiple times a day. For many patients, it can be hard to stay on such a strict schedule. Now, patients have the option of a once-weekly drug for type 2 diabetes.
Jan 30, 2012 11:18AM
FDA Approves Advanced Basal Cell Cancer Drug
Roche announced that Erivedge (vismodegib) capsule was approved by the U.S. Food and Drug Administration (FDA) for adults with a type of skin cancer, called basal cell carcinoma (BCC), that has spread to other parts of the body or that has come back after surgery or that their healthcare provider decides cannot be treated with surgery or radiation.
Jan 03, 2012 10:04AM
Prevnar 13 Approved for New Age Category
Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has granted approval of the Company’s pneumococcal conjugate vaccine Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) as a single dose for use in adults. Prevnar 13 is indicated for adults 50 years of age and older for active immunization for the prevention of pneumonia and invasive disease caused by the 13 Streptococcus pneumoniae (S. pneumoniae) serotypes contained in the vaccine.
Dec 24, 2011 07:36PM
Helping Kids Awaiting Heart Transplant
U.S. Food and Drug Administration officials have given the green light to a device designed to support weakened hearts in children with heart failure who are awaiting a transplant.
Dec 21, 2011 05:11PM
FDA Approves Combo Hypertension Treatment
U.S. Food and Drug Administration officials have approved new combination hypertension drug Edarbyclor, which combines azilsartan medoxomil and chlorthalidone.
Nov 19, 2011 01:37AM
Erwinaze Approved to Treat Leukemia
The U.S. Food and Drug Administration has approved Erwinaze (asparaginase Erwinia chrysanthemi) to treat patients with acute lymphoblastic leukemia (ALL), who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pegapargase chemotherapy drugs used to treat ALL.
Nov 12, 2011 05:51PM
First Cord Blood Product Gets FDA Stamp of Approval
For the first time, U.S. Food and Drug Administration officials have given the green light to an umbilical cord blood product that could be used in stem cell transplants for patients with blood cancer and metabolic or immune disorders.
60 Columbia Road, Building B
Morristown, New Jersey 07960
(800) 432-8534
616 N. North Court, Suite 120
Palatine, Illinois 60067
(847) 705-7709
500 Arsenal Street
Watertown, Massachusetts 02472
(617) 648-8800
4825 Creekstone Dr., Suite 100
Durham, North Carolina 27703-8051
(919) 941-0800
3930 Varsity Drive
Ann Arbor, Michigan 48108
(734) 332-7800
700 Pennsylvania Drive
Exton, Pennsylvania 19341
(484) 595-1500
Advanced Life Sciences Holdings, Inc
1440 Davey Road
Woodridge, Illinois 60517
(630) 739-6744
2500 Millbrook Drive
Buffalo Grove, Illinois 60089
(847) 279-6100
6201 South Freeway
Fort Worth, Texas 76134
(800) 862-5266
300 Atrium Drive
Somerset, New Jersey 08873
(732) 652-4525
P.O. Box 19534
Irvine, California 92623
(800) 433-8871
4660 La Jolla Village Drive, Suite 825
San Diego, California 92122
(858) 410-5200
440 Route 22 East
Bridgewater, New Jersey 08807
(866) 322-2525
125 Sidney Street
Cambridge, Massachusetts 02139
(617) 299-2900
125 CambridgePark Drive, 6th Floor
Cambridge, Massachusetts 02140
(617) 498-3300
One Amgen Center Drive
Thousand Oaks, California 91320-1799
(805) 447-1000
209 McLean Boulevard
Paterson, New Jersey 07504
(973) 357-0222
9360 Towne Centre Drive
San Diego, California 92121
(858) 552-2200
3 Forbes Road
Lexington, Massachusetts 02421-7305
(781) 674-4400
2400 North Commerce Parkway, Suite 400
Weston, Florida 33326
(800) 706-5575
8001 Arista Place, Suite 200
Broomfield, Colorado 80021
(720) 940-2200
Three Parkway North
Deerfield, Illinois 60015
(800) 888-7704
1800 Concord Pike
P.O. Box 15437
Wilmington, Delaware 19850-5437
(800) 236-9933
One Baxter Parkway
Deerfield, Illinois 60015-4625
(800) 422-9837
One Bausch & Lomb Place
Rochester, New York 14604-2701
(585) 338-6000
Bayer Healthcare Pharmaceuticals
6 West Belt
Wayne, New Jersey 07470-6806
(888) 842-2937
BioDelivery Sciences International, Inc.
2501 Aerial Center Parkway, Suite 205
Morrisville, North Carolina 27560
(919) 653-5160
14 Cambridge Center
Cambridge, Massachusetts 02142
(617) 679-2000
Boehringer Ingelheim Pharmaceuticals, Inc
900 Ridgebury Road
P.O. Box 368
Ridgefield, Connecticut 06877
(800) 243-0127
Breckenridge Pharmaceutical, Inc
1141 S. Rogers Circle, Suite 3
Boca Raton, Florida 33487
(800) 367-3395
345 Park Avenue
New York, New York 10154-0037
(212) 546-4000
Caraco Pharmaceutical Laboratories
1150 Elijah McCoy Drive
Detroit, Michigan 48202
(800) 818-4555
800/850 Ridgeview Drive
Horsham, Pennsylvania 19044
(610) 651-6000
41 Moores Road
Frazer, Pennsylvania 19355
(610) 344-0200
300 Connell Drive, Suite 3100
Berkeley Heights, New Jersey 07922
908-516-1350
24840 S Tamiami Trail
Bonita Springs, Florida
34134-7009
(239) 390-0245
Collegium Pharmaceutical, Inc.
400 Highland Corporate Drive
Cumberland, Rhode Island 02864
(401) 762-2000
1020 1st Avenue
King of Prussia, Pennsylvania 19406-0901
(610) 878-4000
4350 Executive Drive, Suite 325
San Diego, California 92121
(858) 452-2323
650 College Road East, Suite 3100
Princeton, New Jersey 08540
(800) 833-3533
Parker Plaza
400 Kelby Street, 10th Floor
Fort Lee, New Jersey 07024
(201) 947-7442
2751 Napa Valley Corporate Drive
Napa, California 94558
(707) 224-3200
1120 Win Drive
Bethlehem, Pennsylvania 18017
(610) 882-5950
2600 Kelly Road, Suite 100
Warrington, Pennsylvania 18976
(215) 488-9300
850 Bear Tavern Road, Suite 201
Ewing, New Jersey 08628
(609) 538-8200
Dr. Reddy's Laboratories, Inc.
200 Somerset Corporate Boulevard, 7th Floor
Bridgewater, New Jersey 08807
(908) 203-4900
300 Technology Square
Cambridge, Massachusetts 02139
(617) 225-2500
100 Tice Boulevard
Woodcliff Lake, New Jersey 07677
(201) 692-1100
225 Franklin Street, Floor 26
Boston, Massachusetts 02110-2804
(800) 252-3526
220 Lake Drive
Newark, Delaware 19702
(800) 462-3636
777 Old Saw Mill River Road
Tarrytown, New York 10591
(914) 606-3500
4 Maguire Road
Lexington, Massachusetts 02421
(781) 761-7600
One Corporate Woods Drive
St. Louis, Missouri 63044
(800) 321-1705
EUSA Pharma Corporate Offices, USA
One Summit Square
1717 Langhorne-Newtown Road Suite 201
Langhorne, PA 19047
(215) 867-4900
909 3rd Avenue
New York, New York 10022
(800) 678-1605, x66297
1 DNA Way
South San Francisco, California 94080-4990
(650) 225-1000
200 Connell Drive
Berkeley Heights, New Jersey 07922
(908) 286-9800
500 Kendall Street
Cambridge, Massachusetts 02142
(617) 252-7500
230 Constitution Drive
Menlo Park, California 94025
(650) 473-7700
333 Lakeside Drive
Foster City, California 94404
(650) 574-3000
1 Franklin Plaza
Philadelphia, Pennsylvania 19101
(888) 825-5249
121 New Britain Boulevard
Chalfont, Pennsylvania 18914
(215) 933-0323
100 Route 206 North
Peapack, New Jersey 07977
(800) 447-3360
175 Crossing Boulevard
PO Box 9322
Framingham, MA 01702
(508) 620-9700
3 N. Dunlap Street, 3rd Floor
Van Vleet Building
Memphis, Tennessee 38163
(901) 523-9700
305 Industrial Parkway South, Unit 3
Aurora, Ontario L4G 6X7
(905) 841-2300 ext. 286
1617 JFK Boulevard, Suite 660
Philadelphia, Pennsylvania 19103
(215) 988-0080
180 Varick Street
New York, New York 10014
(212) 645-1405
30831 Huntwood Avenue
Hayward, California 94544
(510) 476-2000
Route 141 & Henry Clay Road
Building E336
Wilmington, Delaware 19880
(302) 498-6700
75 Adams Avenue
Hauppauge, New York 11788
(631) 952-0214
301 Congress Avenue, Suite 1850
Austin, Texas 78701
(512) 708-9310
1896 Rutherford Road
Carlsbad, California 92008-7326
(760) 931-9200
15295 Alton Parkway
Irvine, California 92618
(949) 788-6000
7164 Technology Drive, Suite 100
Frisco, Texas 75034
(800) 424-9002
1125 Trenton-Harbourton Road
P.O. Box 200
Titusville, New Jersey 08560
(800) 526-7736
Morris Corporate Centre 2
One Upper Pond Road Building D, 3rd Floor
Parsippany, NJ 07054
(973) 658-3530
One Johnson & Johnson Plaza
New Brunswick, New Jersey 08933
(732) 524-0400
501 Fifth Street
Bristol, Tennessee 37620
(800) 776-3637
2503 South Hanley Road
St. Louis, Missouri 63144
(314) 645-6600
110 Terry Drive, Suite 200
Newtown, Pennsylvania 18940
(215) 579-1842
212 Carnegie Center, Suite 101
Princeton, New Jersey 08540
(609) 919-1100
9000 State Road
Philadelphia, Pennsylvania 19136-1615
(215) 333-9000
Lilly Corporate Center
Indianapolis, Indiana 46285
(317) 276-2000
Luitpold Pharmaceuticals, Inc.
1 Luitpold Drive
Shirley, New York 11967
(631) 924-4000
Four Parkway North, Suite 200
Deerfield, Illinois 60015
(847) 282-1000
Harborplace Tower
111 South Calvert Street, 21st Floor
Baltimore, Maryland 21202
(410) 576-2000
675 McDonnell Boulevard
Hazelwood, Missouri 63042
(314) 654-2000
6480 Dobbin Road
Columbia, Maryland 21045
(410) 740-0081
265 Davidson Avenue, Suite 300
Somerset, New Jersey 08873-4120
(732) 564-2200
Medicis Pharmaceutical Corporation
7720 North Dobson Road
Scottsdale, Arizona 85256
(602) 808-8800
22322 20th Avenue, Southeast,
Suite 100
Bothell, Washington 98021
(425) 398-9580
1 MedImmune Way
Gaithersburg, Maryland 20878
(301) 398-0000
One Merck Drive
P.O. Box 100
Whitehouse Station, New Jersey 08889-0100
(908) 423-1000
Morton Grove Pharmaceuticals, Inc.
6451 W. Main Street
Morton Grove, Illinois 60053
(847) 967-5600
1500 Corporate Drive
Canonsburg, Pennsylvania 15317
(724) 514-1800
546 5th Avenue 16F
New York, New York 10036
(212) 703-1340
12790 El Camino Real
San Diego, California 92130
(858) 617-7600
2215 Bridgepointe Parkway, Suite 200
San Mateo, California 94404
(650) 358-3300
89 Twin Rivers Drive
East Windsor, New Jersey 08520
(609) 371-8123
1560 Sherman Avenue, Suite 1000
Evanston, Illinois 60201
(847) 864-3500
25 Minneakoning Road
Flemington, New Jersey 08822
(908) 782-3431
608 Fifth Avenue
New York, New York 10020
(888) 669-6682
11960 S.W. 144th Street
Miami, Florida 33186
(305) 253-5099
100 College Road West
Princeton, New Jersey 08540
(609) 987-5800
1522 217th Place SE, Suite 100
Bothell, Washington 98021
(425) 686-1500
2100 Powell Street
Emeryville, California 94608
(510) 597-6500
430 Route 22 East
Bridgewater, New Jersey 08807-0914
(908) 541-4000
Ortho-McNeil Janssen Scientific Affairs, LLC
1125 Trenton-Harbourton Road
P.O. Box 200
Titusville, New Jersey 08560-200
(0800) 526-7736
1000 Winter Street, Suite 2200
Waltham, Massachusetts 02451
(781) 398-2300
7015 Albert Einstein Drive
Columbia, Maryland 21046
(443) 545-1800
730 Springdale Drive
Exton, Pennsylvania 19341
(484) 879-2800
3940 Quebec Avenue North
Minneapolis, Minnesota 55427
(800) 328-5113
2211 Bridgepointe Parkway, Suite 500
San Mateo, California 94404
(650) 624-8200
300 Tice Boulevard
Woodcliff Lake, New Jersey 07677
(201) 802-4000
932 Southwood Boulevard
Incline Village, Nevada 89451
(775) 832-8500
515 Eastern Avenue
Allegan, Michigan 49010
(269) 673-8451
235 East 42nd Street
New York, New York 10017
(212) 733-2323
995 East Arques Avenue
Sunnyvale, California 94085
(408) 774-0330
1414 Raleigh Road, Suite 400
Chapel Hill, North Carolina 27517
(919) 913-1030
P.O. Box 5572
Cincinnati, Ohio 45201-5572
(800) 764-7483
Progenics Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, New York 10591
(914) 789-2800
7 Wells Avenue
Newton, Massachusetts 02459
(617) 559-0033
130 Vintage Drive
Huntsville, Alabama 35811
(800) 444-4011
600 College Road East, Suite 2100
Princeton, New Jersey 08540
(609) 720-9200
340 Kingsland Street
Nutley, New Jersey 07110
(973) 235-5000
1809 Wilson Rd.
Columbus, Ohio 43216-6532
(800) 962-8364
535 Middlefield Road, Suite 180
Menlo Park, Caslifornia 94025
(650) 322-4554
1700, Perimeter Park Drive
Morrisville, North Carolina 27560
(919) 862-1000
506 Carnegie Center Drive, Suite 400
Princeton, New Jersey 08540
(800) 525-8747
55 Corporate Drive
Bridgewater, New Jersey 08807
(800) 981-2491
One Tower Center, 14th Floor
East Brunswick, New Jersey 08816
(732) 418-9300
2000 Galloping Hill Road
Kenilworth, New Jersey 07033-0530
(908) 298-4000
420 Lexington Avenue, Suite 408
New York, New York 10170
(212) 672-9100
9314 East Broadway Avenue
Tampa, Florida 33619
(813) 496-7325
901 Sawyer Road
Marietta, Georgia 30062
(770) 578-9000
3721 Valley Centre Drive, Suite 500
San Diego, California 92130
(858) 480-0400
12051 Indian Creek Court
Beltsville, Maryland 20705
(301) 419-3900
103 G.P. Clement Drive
Collegeville, Pennsylvania 19426-2044
(800) 533-7546
4140 Dublin Boulevard, Suite 200
Dublin, California 94568
(925) 560-0100
Takeda Pharmaceuticals North America, Inc.
One Takeda Parkway
Deerfield, Illinois 60015
(224) 554-6500
Targanta Therapeutics Corporation
222 Third Street, Suite 2300
Cambridge, Massachusetts 02142
(617) 577-9020
Taro Pharmaceuticals U.S.A., Inc.
3 Skyline Drive
Hawthorne, New York 10532
(800) 544-1449
1090 Horsham Road
P.O. Box 1090
North Wales, Pennsylvania 19454
(888) 838-2872
901 Gateway Boulevard
South San Francisco, California 94080
(650) 808-6000
Transcept Pharmaceuticals, Inc.
1003 W. Cutting Boulevard, Suite 110
Point Richmond, California 94804
(510) 215-3500
Three Rivers Pharmaceuticals, LLC
312 Commerce Park
Cranberry Township, Pennsylvania 16066
(724) 778-6100
1950 Lake Park Drive
Smyrna, Georgia 30080
(770) 970-7500
Upsher-Smith Laboratories, Inc.
6701 Evenstad Drive
Maple Grove, Minnesota 55369
(800) 654-2299
1100 Orthodox Street
Philadelphia, Pennsylvania 19124
800) 523-3684
Valeant Pharmaceuticals International
One Enterprise
Aliso Viejo, California 92656
(800) 548-5100
9605 Medical Center Drive, Suite 300
Rockville, Maryland 20850
(240) 599-4500
130 Waverly Street
Cambridge, Massachusetts 02139
(617) 444-6100
4 Science Park
New Haven, Connecticut 06511
(203) 498-4210
180 Mount Airy Road, Suite 102
Basking Ridge, New Jersey 07920
(908) 766-4400
311 Bonnie Circle
Corona, California 92880
(951) 493-5300
20 Waterview Boulevard, 3rd Floor
Parsippany, New Jersey 07054
(973) 257-4960
5 Giralda Farms
Madison, New Jersey 07940
(610) 902-1200
Xanodyne Pharmaceuticals, Inc.
1 Riverfront Place
Newport, Kentucky 41071-4563
(859) 371-6383
3410 Central Expressway
Santa Clara, California 95051
(408) 616-7200
16430 N. Scottsdale Road, Suite 450
Scottsdale, Arizona 85254
(602) 266-6700
12671 High Bluff Drive, Suite 200
San Diego, California 92130
(858) 259-1165
210 Carnegie Center, Suite 103
Princeton, New Jersey 08540
(609)275-5125