FDA Historical Calendar

TickerCurrent price52 hi52 loProductIndicationPDUFA dateDecisionNotes
PTXLoading...Loading...Loading...TREXIMETAdolescent migraine patients5/14/2015Approved Approved May 15 2015
THRXLoading...Loading...Loading...BREO ELLIPTAAsthma4/30/2015Approved April 30 2015. Approved April 30 2015
MDCOLoading...Loading...Loading...RAPLIXAHemostasis4/30/2015ApprovedApproved April 30 2015
MDCOLoading...Loading...Loading...IONSYSAcute postoperative painApproved5/2/2015
KYTHLoading...Loading...Loading...ATX-101 Reduction of Localized Subcutaneous Fat in the Submental Area5/13/2015ApprovedApproved April 29 2015
LLYLoading...Loading...Loading...CYRAMZASecond-Line Treatment of Metastatic Colorectal CancerApprovedApproved April 24 2015
MNTALoading...Loading...Loading...Generic CopaxoneMultiple sclerosisApprovedFiled 2007. Approved mid April 16 2015
AMGNLoading...Loading...Loading...CorlanorChronic Heart Failure5/27/2015ApprovedApproved April 15 2015
EBSLoading...Loading...Loading...Anthrax Immune Globulin Intravenous (Human) [AIGIV] AnthraxApprovedApproved March 25 2015
VRTXLoading...Loading...Loading...Vacaftor Children ages 2 to 5 with cystic fibrosis who have the G551D or one of the eight additional gating mutations3/17/2015ApprovedApproved March 17 2015
BMYLoading...Loading...Loading...OpdivoAdvanced Squamous Non-Small Cell Lung Cancer6/22/2015ApprovedApproved March 4 2015
PCRXLoading...Loading...Loading...EXPARELSingle-dose injection femoral nerve block for total knee arthroplasty surgery3/5/2015CRLPDUFA CRL March 2 2015.
SNYLoading...Loading...Loading...ToujeoType 1 and type 2 diabetesApprovedApproved Feb 26 2015
ESALY52.15Loading...Loading...Lenvatinib mesylate (lenvatinib)Differentiated thyroid cancer (DTC) 4/14/2015ApprovedApproved Feb 13 2015
PCYCLoading...Loading...Loading...IMBRUVICAWaldenström’s Macroglobulinemia4/17/2015ApprovedApproved Jan 29, 2015
ZGNXLoading...Loading...Loading... Abuse deterrent formulations of Zohydro ERModerate to severe pain1/30/2015ApprovedApproved January 30 2015
RMTILoading...Loading...Loading...Soluble Ferric PyrophosphateIron deficiency1/24/2015ApprovedApproved Jan 26 2015
NPSPNatparaHypoparathyroidism1/24/2015ApprovedApproved Jan 23 2015
IPXLLoading...Loading...Loading...IPX066Parkinson's Approved Jan 8 2015
VRTXLoading...Loading...Loading...KALYDECOCystic fibrosis (CF) ages 6 and older who have the R117H mutation12/30/2014ApprovedApproved Dec 28 2014
ADMSLoading...Loading...Loading...NamzaricModerate to severe dementia of the Alzheimer's type.ApprovedApproved Dec 24 2014
BCRXLoading...Loading...Loading...Peramivir INFLUENZA ACUTE 12/23/2014ApprovedApproved Dec 22 2014
ENTALoading...Loading...Loading...VIEKIRA PAKHCV - genotype 112/21/2014ApprovedApproved December 19 2014
ABBVLoading...Loading...Loading...VIEKIRA PAKHCV - genotype 112/21/2014ApprovedApproved December 19 2014
CBSTLoading...Loading...Loading...Ceftolozane/ tazobactam ZERBAXAComplicated Urinary Tract Infections (cUTI) and Complicated Intra-Abdominal Infections (cIAI)12/21/2014ApprovedApproved Dec 21 2014- priority review
POZNLoading...Loading...Loading...PA32540 and PA8140Cardiovascular patients at risk for developing aspirin-associated gastric ulcers12/30/2014CRLCRL Apr 25 2014. Further CRL issued Dec 17 2014 - due to deficiencies with facility. Intends to schedule a Type A meeting with FDA to address issues
INCYLoading...Loading...Loading...Jakafi Polycythemia Vera5/12/2014ApprovedApproved December 4 2014
AVNRLoading...Loading...Loading...AVP-825Acute migraine11/26/2014CRLCRL November 26 2014 - likely to resubmit 1H 2015
AEZSLoading...Loading...Loading...Macimorelin AcetateAdult Growth Deficiency 11/5/2014CRL New trials required
PGNXLoading...Loading...Loading...Subcutaneous RELISTORChronic pain9/29/2014Approved
SLXPLoading...Loading...Loading...Subcutaneous RELISTORChronic pain9/29/2014Approved
ALIMLoading...Loading...Loading...IluvienDiabetic macular edema9/26/2014Approved Sept 26 2014
PSDVLoading...Loading...Loading...IluvienDiabetic macular edema9/26/2014Approved Sept 26 2014
AUXLLoading...Loading...Loading...AvanafilErectile dysfunction9/20/2014ApprovedApproved 9/18/2014 - sNDA to change label allowing use 15 minutes before sexual activity.
VVUSLoading...Loading...Loading...AvanafilErectile dysfunction9/20/2014ApprovedApproved 9/18/2014 - sNDA to change label allowing use 15 minutes before sexual activity.
NKTRLoading...Loading...Loading...NaloxegolOpioid-induced constipation (OIC)9/16/2014ApprovedApproved Sept 16 2014
SLXPLoading...Loading...Loading...Budesonide foamModerate ulcerative proctitis or proctosigmoiditis 9/15/2014Tentative approvalTentative approval granted September 15 2014 pending patent issues
HALOLoading...Loading...Loading...HYQVIASubcutaneous treatment for patients with primary immunodeficiency (PI)ApprovedApproved Sept 12 2014
OREXLoading...Loading...Loading...ContraveObesity9/11/2014ApprovedApproved September 11 2014
MDVNLoading...Loading...Loading...XTANDICancer - mCRPC who have not received chemotherapy9/17/2014ApprovedApproved Sept 10 2014
KERXLoading...Loading...Loading...ZerenexHyperphosphatemia9/7/2014ApprovedApproved Sept 5 2014
LGNDLoading...Loading...Loading...PromactaAplastic AnemiaApproved Approved August 27 2014
MDCOLoading...Loading...Loading...OritavancinABSSSI8/6/2014ApprovedApproved under priority review
PCYCLoading...Loading...Loading...Ibrutinib Deletion 17pApprovedApproved July 29 2014
PCYCLoading...Loading...Loading...Ibrutinib Cancer - Refractory Chronic Lymphocytic Leukemia/Small Cell Lymphocytic Lymphoma (CLL/SLL)ApprovedApproved July 29 2014
ACRXLoading...Loading...Loading...ZalvisoPost-operative pain following open abdominal surgery and hip or knee replacement surgery7/27/2014CRLCRL Jul 26 2014
EGRXLoading...Loading...Loading...RyanodexMalignant hyperthermia7/22/2014Approved
SLXPLoading...Loading...Loading...RUCONESTHereditary angioedema (HAE)7/16/2014Approved Partnered with Dutch company Pharming
ANACLoading...Loading...Loading...TavaboroleOnychomycosis7/29/2014ApprovedApproved July 8 2014
SPPILoading...Loading...Loading...BelinostatCancer - Peripheral T-Cell Lymphoma8/9/2014ApprovedApproved two months early under accelerated approval program.
EGRXLoading...Loading...Loading...EP-3101 (bendamustine RTD) Chronic lymphocytic leukemia; Indolent non-Hodgkin's lymphoma7/6/2014Approved - tentativeTentative approval (July 2 2014) will convert to a final approval subject to patent litigation with Teva Pharmaceutical
FLMLLoading...Loading...Loading...VAZCULEP (phenylephrine hydrochloride)Clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia8/6/2014ApprovedApproved June 30 2014. PDUFA of August 6 was for a resubmission following CRL
NPSPLoading...Loading...Loading...GATTEXShort Bowel Syndrome 7/28/2014ApprovedsNDA - seeking additions to label
MNKDLoading...Loading...Loading...AFREZZA Type 1/2 diabetes7/15/2014ApprovedApproved June 27 2014
CBSTLoading...Loading...Loading...Tedizolid phosphateAcute bacterial skin and skin structure infections (ABSSSI)6/22/2014Approved Approved June 20 2014
NAVBLoading...Loading...Loading...LymphoseekHead and Neck Cancer6/16/2014ApprovedApproved Jun 13 2014
BDSILoading...Loading...Loading...BEMA Buprenorphine/Naloxone (BNX) - BUNAVAILOpioid dependence6/7/2014ApprovedApproved June 7 2014
OMERLoading...Loading...Loading...OmidriaCataract surgery6/1/2014Approved Approved June 2 2014
TRLPFLoading...Loading...Loading...Loading...PDUFA5/28/2014PDUFA date February 28 2014, extended to May 28 2014, for bioadhesive intranasal gel testosterone product (CompleoTRT)
QRXPYLoading...Loading...Loading...MOXDUOModerate to severe acute pain5/25/2014CRL
DRTXLoading...Loading...Loading...DalbavancinAcute bacterial skin and skin structure infections (ABSSSI)5/26/2014ApprovedApproved May 23 2014
FLMLLoading...Loading...Loading...??????4/28/2014CRLCRL April 28 2014
MDCOLoading...Loading...Loading...CangrelorReduction of thrombotic cardiovascular events including stent thrombosis in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI).4/30/2014CRLCRL April 30 2014
POZNLoading...Loading...Loading...PA32540 and PA8140Cardiovascular patients at risk for developing aspirin-associated gastric ulcers4/25/2014CRLCRL Apr 25 2014 - manufacturing deficiencies
TSX:PLBImpavidoTropical disease leishmaniasis3/19/2014ApprovedApproved Mar 19
BMYLoading...Loading...Loading...Eliquis To Reduce The Risk Of Blood Clots Following Hip Or Knee Replacement Surgery3/15/2014ApprovedApproved March 14 2014
PFELoading...Loading...Loading...EliquisTo Reduce The Risk Of Blood Clots Following Hip Or Knee Replacement Surgery3/15/2014ApprovedApproved March 14 2014
ENDPLoading...Loading...Loading...AVEED (testosterone undecanoate) intramuscular injectionMen diagnosed with hypogonadism3/28/2014ApprovedApproved March 6 2014
AZNLoading...Loading...Loading...MetreleptinLipodystrophy2/27/2014ApprovedApproved Feb 25 2014
BMYLoading...Loading...Loading...MetreleptinLipodystrophy2/27/2014ApprovedApproved Feb 25 2014
CHTPNORTHERA Neurogenic Orthostatic HypotensionApprovedApprovedApproved one day late due to snow. Acquired by Lundbeck
BMRNLoading...Loading...Loading...Vimizim (GALNS)(MPS IVA) Morquio A Syndrome2/28/2014Approved Early approval. Was under priority review
DRRXLoading...Loading...Loading...PosidurPost-operative pain relief 2/12/2014CRL
PCYCLoading...Loading...Loading...Ibrutinib Cancer - Chronic Lymphocytic Leukemia Who Have Received at Least One Prior Therapy2/28/2014ApprovedApproved Feb 12 2014
VNDALoading...Loading...Loading...HETLIOZ (tasimelteon)Non-24-Hour Sleep-Wake Disorder1/31/2014Approved
VRXLoading...Loading...Loading...Retin-A Micro (tretinoin) Gel microsphere 0.08% Acne vulgarisApprovedsNDA
AMAGLoading...Loading...Loading...FerahemeIron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD) to all adult patients with IDA who have failed or could not tolerate oral iron treatment1/21/2014CRLOriginal PDUFA date delayed
AZNLoading...Loading...Loading...FARXIGA (dapagliflozin) tablets Adult patients with type 2 diabetesApproved
BMYLoading...Loading...Loading...FARXIGA (dapagliflozin) tabletsAdult patients with type 2 diabetesApproved
GSKLoading...Loading...Loading...Mekinist (trametinib) and Tafinlar (dabrafenib)Unresectable melanoma or metastatic melanoma with BRAF V600E or V600K mutationsApprovedAccelerated approval based on Phase 2 trial. Approval coningent on Phase 3 trial outcome
MRKLoading...Loading...Loading...ISENTRESS for oral suspensionHIV-1 infected infants and childrenApproved
AZNLoading...Loading...Loading...Forxiga (dapagliflozin)Type 2 diabetes1/11/2014ApprovedApproved three days prior to PDUFA
BMYLoading...Loading...Loading...Forxiga (dapagliflozin)Type 2 diabetes1/11/2014ApprovedApproved three days prior to PDUFA
SNYLoading...Loading...Loading...LemtradaRelapsing forms of multiple sclerosis.CRLCRL 29/12/13
UTHRLoading...Loading...Loading...Oral treprostinilPulmonary arterial hypertension (PAH)2/16/2014ApprovedApproved Dec 20 2013. Early approval following previous extension
THRXLoading...Loading...Loading...UMEC/VI (62.5/25mcg and 125/25mcg doses) ANORO ELLIPTAChronic Obstructive Pulmonary Disease (COPD)12/18/2013ApprovedApproved Dec 18 2013
JNJLoading...Loading...Loading...Canagliflozin and immediate-release metforminAdults with type 2 diabetesCRL
GILDLoading...Loading...Loading...Sovaldi (Sofosbuvir)HCV6/12/2013Approved
AUXLLoading...Loading...Loading...XIAFLEXPeyronie’s6/12/2013ApprovedApproved Dec 6 2013
PCYCLoading...Loading...Loading...Ibrutinib versus temsirolimus - RAY (MCL3001)Cancer - relapsed or refractory MCL mantle cell lymphoma2/28/2013Approved Approved Nov 13 2013, 3 months early. Was under priority review
ZGNXLoading...Loading...Loading...Zohydro ERModerate to severe painApprovedApproved Oct 25 2013. Decision was delayed by several months
AGNLoading...Loading...Loading...JUVÉDERM VOLUMA XCAge-related volume loss in the cheek area in adults over the age of 21ApprovedApproved Oct 23 2013
ALIOFLoading...Loading...Loading...Macitentan (Opsumit)Pulmonary arterial hypertension10/18/2013ApprovedApproved Oct 18 2013
ALIMLoading...Loading...Loading...IluvienDiabetic macular edema10/17/2013CRLCRL Nov 2011. Second CRL Oct 17 2013. Adcom meeting Jan 27 2014
PSDVLoading...Loading...Loading...IluvienDiabetic macular edema10/17/2013CRLCRL Nov 2011. Second CRL Oct 17 2013. Adcom meeting Jan 27 2014
ATRSLoading...Loading...Loading...OTREXUPRheumatoid arthritis (RA)10/14/2013ApprovedApproved Oct 14 2013
DCTHLoading...Loading...Loading...CHEMOSAT systemCancer - unresectable metastatic ocular melanoma in the liver9/13/2013CRL CRL Sept 13 2013
CELGLoading...Loading...Loading...ABRAXANEMetastatic pancreatic cancer9/21/2013ApprovedApproved Sep 6 2013
QRXPYLoading...Loading...Loading...MOXDUOModerate to severe acute pain8/26/2013CRLCRL Aug 2013. Expects to resubmit 4Q 2013. Expects Adcom meeting
SUPNLoading...Loading...Loading...Trokendi XR SPN-538EpilepsyApprovedApproved Aug 19 2013
JNJLoading...Loading...Loading...SIMPONI ARIARheumatoid ArthritisApprovedApproved Jul 18 2013
MRKLoading...Loading...Loading...Suvorexant tabletsInsomniaCRLAdcom May 22 2013. 13-3 positive vote. CRL received Jul 1 2013
GSKLoading...Loading...Loading...Dolutegravir - ViiV HealthcareHIV8/17/2013ApprovedPDUFA Aug 12 under priority review.
JNJLoading...Loading...Loading...XARELTO (rivaroxaban)Stent Thrombosis in Patients with Acute Coronary SyndromeCRLCRL issued Jun 28 2013
THRXLoading...Loading...Loading...VIBATIV (telavancin hydrochloride) for injectionHospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP)ApprovedApproved Jun 21 2013
AMGNLoading...Loading...Loading...XGEVACancer - Giant Cell Tumor Of BoneApprovedApproved 6/13/13
AVEOLoading...Loading...Loading...TivozanibCancer - advanced renal cell carcinoma7/28/2013CRLNegative 1-13 vote at Adcom meeting May 2 2013.Early CRL Jun 10 2013
CELGLoading...Loading...Loading...REVLIMIDCancer - relapsed/refractory mantle cell lymphomaApproved Approved Jun 5 2013 under priority review
FLMLLoading...Loading...Loading...Bloxiverz (neostigmine methylsulfate)Reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery5/31/2013ApprovedApproved Jun 3 2013
DEPOLoading...Loading...Loading...SEFELSAHot flashes5/31/2013CRLCRL May 31 2013
ENDPLoading...Loading...Loading...AVEED (testosterone undecanoate) intramuscular injectionMen diagnosed with hypogonadismCRLCRL issued May 30 2013. Expects to respond 3Q 2013
GSKLoading...Loading...Loading...DabrafenibCancer - melanoma6/3/2013Approved Approved May 29 2013
GSKLoading...Loading...Loading...TrametinibCancer - melanoma6/3/2013ApprovedApproved May 29 2013
VRXLoading...Loading...Loading...EfinaconazoleOnychomycosis5/24/2013CRLCRL May 28 2013
JNJLoading...Loading...Loading...SIMPONI (golimumab) ulcerative colitis (UC)ApprovedApproved May 16
THRXLoading...Loading...Loading...BREO ELLIPTAChronic Obstructive Pulmonary Disease (COPD)5/12/2013ApprovedApproved May 10 2013
GSKLoading...Loading...Loading...BREO ELLIPTAChronic Obstructive Pulmonary Disease (COPD)5/12/2013ApprovedApproved May 10 2013
BMYLoading...Loading...Loading...SUSTIVA® (efavirenz)HIV-1ApprovedsNDA approved May 3 2013
MRKLoading...Loading...Loading...LIPTRUZET (ezetimibe and atorvastatin)LDL CholesterolApprovedApproved May 3 2013
SHPGLoading...Loading...Loading...Vyvanse® (lisdexamfetamine dimesylate) Children and Adolescents with ADHD5/1/2013ApprovedApproved May 1 2013
TTNPLoading...Loading...Loading...ProbuphineOpioid dependence4/30/2013CRLCRL issued midnight Apr 30
RPTPLoading...Loading...Loading...DR CysteamineCystinosis4/30/2013ApprovedApproved Apr 30, 2013.
GILDLoading...Loading...Loading...ElvitegravirHIV4/27/2013CRLCRL Apr 29 2013
GILDLoading...Loading...Loading...CobicistatHIV4/28/2013CRLCRL Apr 29 2013
SCMPLoading...Loading...Loading...Amitiza/ LubiprostoneOpioid-induced bowel dysfunction4/24/2013ApprovedApproved Apr 23 2013
NVSLoading...Loading...Loading...Simbrinza(TM) SuspensionGlaucomaApprovedApproved Apr 19 2013
JNJLoading...Loading...Loading...InvokanaType 2 diabetes3/31/2013ApprovedApproved Mar 29 2013
APPALoading...APF530Prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV)3/27/2013CRLCRL Mar 28 2013. Changed ticker to HRTX
UTHRLoading...Loading...Loading...Treprostinil diolamine extended release tablets (oral treprostinil)Pulmonary arterial hypertension3/31/2013CRLCRL Mar 25, 6 days early
NAVBLoading...Loading...Loading...LymphoseekLymphatic-tissue tracing agent4/30/2013Approved Approved Mar 13 2013. 7 weeks early.
JNJLoading...Loading...Loading...XARELTOReduction of the risk of cardiovascular events in patients with acute coronary syndrome (ACS)3/5/2013CRLCRL March 5 2013
ONXXStivargaMetastatic and/or unresectable gastrointestinal stromal tumors (GIST)2/25/2013ApprovedApproved Feb 25 2013. Acquired by Amgen.
DVAXLoading...Loading...Loading...HEPLISAVHepatitis B2/24/2013CRLCRL Feb 25 2013. Hopes to meet with FDA by mid April to discuss CRL
IMGNLoading...Loading...Loading...KadcylaCancer - 2nd-line HER2+ Metastatic Breast Cancer2/26/2013ApprovedApproved Feb 22 2013 - under priority review
NVSLoading...Loading...Loading...Zortress (everolimus)Prevent organ rejection in adult liver transplant patientsApprovedApproved Feb 15 2013
CELGLoading...Loading...Loading...PomalystCancer - Multiple Myeloma2/10/2013ApprovedApproved Feb 8 2013
HEBLoading...Loading...Loading...Ampligen CFS2/4/2013CRLCRL Feb 4 2012. Resubmission. More trials required. Intends to appeal
HPTXLoading...Loading...Loading...RavictiUrea cycle disorders1/22/2013ApprovedApproved Feb 1 2013. FDA had advised company of delay
FURXLoading...Loading...Loading...AlogliptinDiabetes - Type 21/27/2013Approved NDA resubmitted July 27 2012, following CRL. Approved Jan 25 2013
IPXLLoading...Loading...Loading...IPX066Parkinson's 1/21/2013CRLCRL January 21 2013
PATHZecuity Migraine1/17/2013ApprovedApproved Jan 17 2013. Acquired by TEVA.
SNTSBudesonideUCERIS (Budesonide)Ulcerative colitis disease1/16/2013ApprovedApproved Jan 14 2013, two days early. Acquired by Salix.
AEGRLoading...Loading...Loading...LomitapideHomozygous familial hypercholesterolemia (HoFH)1/6/2013ApprovedEarly approval Dec 24 2012
ALXALoading...Loading...Loading...Staccato loxapine (ADASUVE). Schizophrenia12/21/2012Approved
NPSPLoading...Loading...Loading...GattexShort bowel syndrome or SBS12/30/2012ApprovedPDUFA date was Dec 30 2012. Early approval on Dec 21
ARIALoading...Loading...Loading...Oral ponatinibCancer - chronic myeloid leukemia, acute lymphoblastic leukemia3/27/2013ApprovedPDUFA March 27 2013. Early approval Dec 14 2012 under priority review
EXELLoading...Loading...Loading...CabozantinibCancer - Medullary thyroid 11/29/2012ApprovedApproved Nov 29 2012 under priority review
LGNDLoading...Loading...Loading...Promacta/RevoladeThrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C11/30/2012ApprovedApproved Nov 19 2012 under priority review, 11 days prior to PDUFA date
CRTXCRTX 080Hyponatremia10/29/2012CRLAdditional clinical and non-clinical information required. Acquired by Chiesi Farmaceutici S.p.A
SUPNLoading...Loading...Loading...OxtellarEpilepsy10/22/2012Approved
NAVBLoading...Loading...Loading...LymphoseekLymphatic-tissue tracing agent9/10/2012CRL3rd party manufacturing deficiencies cited
MDVNLoading...Loading...Loading...MDV3100Cancer - prostate 2nd line8/31/2012Approved Early approval decision by 3mths approx. Was under priority review
TLONLoading...Loading...Loading...Marqibo2nd line adult Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL)8/12/2012Approved Approved 8/9/2012
HALOLoading...Loading...Loading...HyQPrimary immunodeficiency diseaseCRL
PGNXLoading...Loading...Loading...Subcutaneous RELISTORchronic pain7/27/2012CRLPrice shown is for PGNX. Partnered with SLXP
AMRNLoading...Loading...Loading...Vascepa Elevated triglyceride levels7/26/2012Approved
HZNPLoading...Loading...Loading...LODOTRA (RAYOS)Rheumetoid Arthritis7/26/2012Approved
ONXXCarfilzomibMultiple myeloma7/20/2012ApprovedAcquired by Amgen.
VVUSLoading...Loading...Loading...QnexaObesity7/18/2012Approved
ARNALoading...Loading...Loading...LorcaserinObesity6/27/2012Approved
QRXLoading...Loading...Loading...MOXDUOModerate to severe acute pain6/26/2012CRL
RGENLoading...Loading...Loading...RG1068Detection of pancreatic duct abnormalities6/22/2012CRL
XNPTLoading...Loading...Loading...HorizantPostherpetic Neuralgia6/9/2012Approved
ARIALoading...Loading...Loading...RidaforolimusSoft tissue or bone sarcoma6/6/2012CRL
EBSLoading...Loading...Loading...BioThraxAnthrax Vaccine5/17/2012ApprovedApproved May 17 2012
TLONLoading...Loading...Loading...MarqiboPhiladelphia chromosome-negative acute lymphoblastic leukemia 5/13/2012Extended
ALXALoading...Loading...Loading...ADASUVESchizophrenia5/3/2012CRL
PLXLoading...Loading...Loading...Taliglucerase alfa Gaucher disease5/1/2012Approved
VVUSLoading...Loading...Loading...AvanafilErectile dysfunction4/29/2012Approved
PGNXLoading...Loading...Loading...Subcutaneous RELISTORChronic pain4/27/2012ExtendedPrice shown is for PGNX
FURXLoading...Loading...Loading...AlogliptinDiabetes - Type 24/25/2012CRL
VVUSLoading...Loading...Loading...QnexaObesity4/17/2012Extended
CHTPNORTHERA Neurogenic Orthostatic Hypotension3/28/2012CRLAcquired by Lundbeck
AFFYLoading...Loading...Loading...PeginesatideAnemia in chronic renal failure (CRF)3/27/2012ApprovedBankrupt
MAPPLevadexMigraine3/26/2012CRLAcquired by Allergan
CRISLoading...Loading...Loading...VismodegibBasal Cell Carcinoma3/8/2012ApprovedEarly decision Jan 30,2012
NGSXLoading...Loading...Loading...QutenzaNeuropathic pain associated with HIV-associated peripheral neuropathy (HIV-PN)3/7/2012CRL
DSCOLoading...Loading...Loading...Surfaxin Respiratory Distress Syndrome - Severe3/6/2012Approved
ASTXDacogenAcute myeloid leukemia3/6/2012CRLAcquired by Otsuka
CBRXLoading...Loading...Loading...Progesterone vaginal gelReduction of risk of preterm birth2/26/2012CRL
CORTLoading...Loading...Loading...Corlux - KorlymCushing's Syndrome2/17/2012Approved
BPAXBio-T-GelMale hypogonadism2/14/2012ApprovedMerged. New ticker ANIP
ALXALoading...Loading...Loading...ADASUVESchizophrenia2/4/2012Extended 3months
AMLNBYDUREONType 2 diabetes1/28/2012ApprovedAcquired by Bristol-Myers Squibb
ALKSLoading...Loading...Loading...BYDUREONType 2 diabetes1/28/2012Approved
PLXLoading...Loading...Loading...Taliglucerase alfa Gaucher disease1/2/2012Extended 3 monthsInformed Dec 6 2011
NEOLSUBSYSCancer pain1/1/2012ApprovedNew ticker INSY
AISLoading...Loading...Loading...AnturolOveractive bladder12/8/2011ApprovedChanged ticker to ATRS
INCYLoading...Loading...Loading...JakafiMyelofibrosis12/3/2011ApprovedApproved Nov 16 2011
TSPTLoading...Loading...Loading...IntermezzoInsomnia11/27/2011Approved
SPPILoading...Loading...Loading...Removal of the Bioscan Requirement for ZevalinNon-Hodgkin's lymphoma11/20/2011Approved
ALIMLoading...ILUVIENDiabetic macular edema11/12/2011CRLEarly CRL. Price shown is for ALIM
IGXTLoading...Loading...Loading...CPI-300Major Depressive Disorder11/10/2011Approved
PCRXLoading...Loading...Loading...EXPARELPostsurgical pain10/28/2011Approved
SGENLoading...Loading...Loading...ADCETRISHodgkin lymphoma8/30/2011Approved
SGENLoading...Loading...Loading...ADCETRISAnaplastic large cell lymphoma8/30/2011Approved
PATHZelrixMigraine8/29/2011CRLAcquired by TEVA.
MSTXLoading...Loading...Loading...ExelbineNSCLC8/9/2011CRLNew ticker MSTX. Formerly ANX
TSPTLoading...Loading...Loading...IntermezzoInsomnia7/14/2011CRL
PTIELoading...Loading...Loading...REMOXYModerate to severe pain6/23/2011CRL
FCSCLoading...Loading...Loading...LavivWrinkles6/22/2011Approved
ACURLoading...Loading...Loading...OxectaPain relief6/17/2011Approved
OPTRFidaxomicinCDI - diarrhea5/30/2011Approved
SPPILoading...Loading...Loading...FUSILEVColorectal cancer4/29/2011Approved
XNPTLoading...Loading...Loading...HorizantRestless Legs Syndrome4/6/2011Approved
HGSILoading...BENLYSTALupus3/10/2011Approved
PLXLoading...Loading...Loading...Taliglucerase alfa Gaucher disease2/25/2011CRL
OREXLoading...Loading...Loading...ContraveObesity1/31/2011CRL
DEPOLoading...Loading...Loading...GRALISEPostherpetic neuralgia - shingles1/30/2011Approved
MNKDLoading...Loading...Loading...AfrezzaInsulin1/26/2011CRLEarly CRL
CLDALoading...ViibrydMajor depressive disorder1/23/2011ApprovedAcquired by Forest Laboratories (FRX)
PSDV/ALIMLoading...ILUVIENDiabetic macular edema12/29/2010CRLEarly CRL. Price shown is for ALIM
CADXLoading...OFIRMEVPain and fever11/4/2010Approved
BIODLoading...Loading...Loading...VIAjectDiabetes10/30/2010CRL
AVNRLoading...Loading...Loading...NUEDEXTAPseudobulbar affect10/30/2010Approved
VVUSLoading...Loading...Loading...QnexaObesity10/28/2010CRL
ALKS/AMLNLoading...BYDUREONType 2 diabetes10/22/2010CRL
ISTALoading...BROMDAYPostoperative inflammation and reduction of ocular pain10/16/2010ApprovedAcquired by Bausch + Lomb
QCORLoading...Loading...Loading...ActharInfantile spasms10/15/2010Approved
ALXALoading...Loading...Loading...ADASUVESchizophrenia10/11/2010CRL
JAZZLoading...Loading...Loading...JZP-6Fibromyalgia10/11/2010CRL
HGSIZALBINHepatitis C10/5/2010CRLAcquired by GSK
PGNXLoading...Loading...Loading...RelistorOpioid-induced constipation (OIC)9/29/2010Approved
SVNTKRYSTEXXAGout9/14/2010ApprovedBankrupt
QCORLoading...Loading...Loading...ActharInfantile spasms6/11/2010Extended 4 months
POZNLoading...Loading...Loading...VIMOVOGastric ulcers4/30/2010Approved
ITMNLoading...Loading...Loading...EsbrietIdiopathic pulmonary fibrosis 4/5/2010CRL
SLXPLoading...Loading...Loading...XIFAXANHepatic encephalopathy3/24/2010Approved
CTICLoading...Loading...Loading...PixuvriNon-Hodgkin's lymphoma3/23/2010CRL
SOMXLoading...Loading...Loading...SilenorInsomnia3/19/2010Approved
APPALoading...APF530Chemotherapy-induced nausea and vomiting3/18/2010CRLChanged ticker to HRTX
SUPGLoading...DacogenMyelodysplastic syndromes3/8/2010ApprovedChanged ticker to ASTX
ALKSLoading...BYDUREONType 2 diabetes3/5/2010CRLPrice shown is for ALKS
CRXXExalgoModerate to severe pain in opioid tolerant patients3/2/2010ApprovedChanged ticker to ZLCS
CADXOFIRMEVPain and fever2/12/2010CRL
DDSSLoading...OleptroMajor depressive disorder2/11/2010ApprovedBankrupt
XNPTLoading...Loading...Loading...HorizantRestless Legs Syndrome2/9/2010CRL
PLXLoading...Loading...Loading...Taliglucerase alfa Gaucher disease2/9/2010Extended
ACORLoading...Loading...Loading...AMPYRAImprove walking in patients with multiple sclerosis1/22/2010Approved
MNKDLoading...Loading...Loading...AFREZZADiabetes1/16/2010CRLFDA responded 15 Mar 2010
FCSCLoading...Loading...Loading...LavivWrinkles1/4/2010CRLEarly CRL
VIONOnriginAcute myeloid leukemia12/12/2009CRLBankrupt
SOMXLoading...Loading...Loading...SilenorInsomnia12/4/2009CRL
SNTSZEGERIDGERD12/4/2009ApprovedAcquired by Salix.
DYAXLoading...Loading...Loading...KALBITORHereditary angioedema 12/1/2009Approved
NGSXLoading...Loading...QutenzaPostherpetic neuralgia11/16/2009Approved
CADXOFIRMEVMild to moderate pain11/13/2009Approved
TSPTLoading...Loading...Loading...IntermezzoInsomnia11/2/2009CRL
GTXILoading...Loading...Loading...ToremifeneReduce fractures in men with prostate cancer10/30/2009CRL
SPPILoading...Loading...Loading...FUSILEVColorectal cancer10/8/2009CRL
ALTHLoading...Loading...FOLOTYNPeripheral T-cell lymphoma9/24/2009Approved
ISTABepreveAllergic conjunctivitis9/14/2009ApprovedAcquired by Bausch + Lomb
SPPILoading...Loading...Loading...ZEVALINNon-Hodgkin's Lymphoma 9/7/2009Approved
NGSXLoading...Loading...Loading...QutenzaPostherpetic neuralgia8/17/2009Extended 3 months
SVNTKRYSTEXXAGout8/3/2009CRLBankrupt
DDSSLoading...OleptroMajor depressive disorder7/20/2009CRLBankrupt
ZGNXLoading...Loading...Loading...SumavelMigraine7/15/2009Approved
ARDMLoading...SumavelMigraine7/15/2009Approved
SPPILoading...Loading...Loading...ZEVALINNHL7/2/2009CRL
HEBLoading...Loading...Loading...AmpligenChronic fatigue syndrome5/25/2009CRLCRL PR released Dec 1, 2009. PDUFA date was May 25, 2009. FDA advised only of a 1-2 week delay

About the author

Currently residing in New Zealand and employed in the education industry, Mr. A. Burden holds a M.Com in International Business from the University of Sydney and used these skills together with his passion for investing to establish BioPharmCatalyst in June 2010 as a tool for investing decisions in the US pharmaceutical market. He spends much of his free time mountain biking, playing squash and hiking.

2 Responses to “FDA Historical Calendar”

  1. Chirag says:

    a thousand thanks !!

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