FDA Historical Calendar

TickerCurrent price52 hi52 loProductIndicationPDUFA dateDecisionNotes
ALIM5.338.441.65IluvienDiabetic macular edema9/26/2014Approved Sept 26 2014
PSDV4.305.602.28IluvienDiabetic macular edema9/26/2014Approved Sept 26 2014
AUXL30.4432.8916.36AvanafilErectile dysfunction9/20/2014ApprovedApproved 9/18/2014 - sNDA to change label allowing use 15 minutes before sexual activity.
VVUS4.0211.643.32AvanafilErectile dysfunction9/20/2014ApprovedApproved 9/18/2014 - sNDA to change label allowing use 15 minutes before sexual activity.
NKTR12.5915.348.87NaloxegolOpioid-induced constipation (OIC)9/16/2014ApprovedApproved Sept 16 2014
SLXP155.78172.9865.93Budesonide foamModerate ulcerative proctitis or proctosigmoiditis 9/15/2014Tentative approvalTentative approval granted September 15 2014 pending patent issues
HALO9.4518.186.88HYQVIASubcutaneous treatment for patients with primary immunodeficiency (PI)ApprovedApproved Sept 12 2014
OREX4.527.824.32ContraveObesity9/11/2014ApprovedApproved September 11 2014
MDVN100.25103.8848.15XTANDICancer - mCRPC who have not received chemotherapy9/17/2014ApprovedApproved Sept 10 2014
KERX13.7018.488.61ZerenexHyperphosphatemia9/7/2014ApprovedApproved Sept 5 2014
LGND47.6180.4240.81PromactaAplastic AnemiaApproved Approved August 27 2014
MDCO23.2841.2822.67OritavancinABSSSI8/6/2014ApprovedApproved under priority review
PCYC120.54154.8982.51Ibrutinib Deletion 17pApprovedApproved July 29 2014
PCYC120.54154.8982.51Ibrutinib Cancer - Refractory Chronic Lymphocytic Leukemia/Small Cell Lymphocytic Lymphoma (CLL/SLL)ApprovedApproved July 29 2014
ACRX5.9013.645.27ZalvisoPost-operative pain following open abdominal surgery and hip or knee replacement surgery7/27/2014CRLCRL Jul 26 2014
EGRX12.1616.449.16RyanodexMalignant hyperthermia7/22/2014Approved
SLXP155.78172.9865.93RUCONESTHereditary angioedema (HAE)7/16/2014Approved Partnered with Dutch company Pharming
ANAC25.1325.7810.00TavaboroleOnychomycosis7/29/2014ApprovedApproved July 8 2014
SPPI8.2510.326.36BelinostatCancer - Peripheral T-Cell Lymphoma8/9/2014ApprovedApproved two months early under accelerated approval program.
EGRX12.1616.449.16EP-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
FLML14.5815.965.30VAZCULEP (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
NPSP27.0339.6821.60GATTEXShort Bowel Syndrome 7/28/2014ApprovedsNDA - seeking additions to label
MNKD6.0811.483.80AFREZZA Type 1/2 diabetes7/15/2014ApprovedApproved June 27 2014
CBST66.4982.1258.50Tedizolid phosphateAcute bacterial skin and skin structure infections (ABSSSI)6/22/2014Approved Approved June 20 2014
NAVB1.332.751.11LymphoseekHead and Neck Cancer6/16/2014ApprovedApproved Jun 13 2014
BDSI17.6018.484.16BEMA Buprenorphine/Naloxone (BNX) - BUNAVAILOpioid dependence6/7/2014ApprovedApproved June 7 2014
OMER12.9518.806.92OmidriaCataract surgery6/1/2014Approved Approved June 2 2014
TRLPF0.290.850.29Loading...PDUFA5/28/2014PDUFA date February 28 2014, extended to May 28 2014, for bioadhesive intranasal gel testosterone product (CompleoTRT)
QRXPY0.084.350.08MOXDUOModerate to severe acute pain5/25/2014CRL
DRTX13.0418.178.44DalbavancinAcute bacterial skin and skin structure infections (ABSSSI)5/26/2014ApprovedApproved May 23 2014
FLML14.5815.965.30??????4/28/2014CRLCRL April 28 2014
MDCO23.2841.2822.67CangrelorReduction of thrombotic cardiovascular events including stent thrombosis in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI).4/30/2014CRLCRL April 30 2014
POZN7.619.905.35PA32540 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
BMY51.7157.4945.70Eliquis To Reduce The Risk Of Blood Clots Following Hip Or Knee Replacement Surgery3/15/2014ApprovedApproved March 14 2014
PFE29.7732.9627.87EliquisTo Reduce The Risk Of Blood Clots Following Hip Or Knee Replacement Surgery3/15/2014ApprovedApproved March 14 2014
ENDP69.5282.1643.12AVEED (testosterone undecanoate) intramuscular injectionMen diagnosed with hypogonadism3/28/2014ApprovedApproved March 6 2014
AZN71.9582.6849.63MetreleptinLipodystrophy2/27/2014ApprovedApproved Feb 25 2014
BMY51.7157.4945.70MetreleptinLipodystrophy2/27/2014ApprovedApproved Feb 25 2014
CHTPNORTHERA Neurogenic Orthostatic HypotensionApprovedApprovedApproved one day late due to snow. Acquired by Lundbeck
BMRN73.0084.2555.04Vimizim (GALNS)(MPS IVA) Morquio A Syndrome2/28/2014Approved Early approval. Was under priority review
DRRX1.482.691.20PosidurPost-operative pain relief 2/12/2014CRL
PCYC120.54154.8982.51Ibrutinib Cancer - Chronic Lymphocytic Leukemia Who Have Received at Least One Prior Therapy2/28/2014ApprovedApproved Feb 12 2014
VNDA10.5719.255.70HETLIOZ (tasimelteon)Non-24-Hour Sleep-Wake Disorder1/31/2014Approved
VRX130.26153.10102.60Retin-A Micro (tretinoin) Gel microsphere 0.08% Acne vulgarisApprovedsNDA
AMAG29.7229.8416.49FerahemeIron 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
NRIFF4.445.201.54Pennsaid 2%Pain of osteoarthritis of the knee2/7/2014ApprovedApproved Jan 17 2014
AZN71.9582.6849.63FARXIGA (dapagliflozin) tablets Adult patients with type 2 diabetesApproved
BMY51.7157.4945.70FARXIGA (dapagliflozin) tabletsAdult patients with type 2 diabetesApproved
GSK46.2956.7346.01Mekinist (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
MRK59.4161.3344.62ISENTRESS for oral suspensionHIV-1 infected infants and childrenApproved
AZN71.9582.6849.63Forxiga (dapagliflozin)Type 2 diabetes1/11/2014ApprovedApproved three days prior to PDUFA
BMY51.7157.4945.70Forxiga (dapagliflozin)Type 2 diabetes1/11/2014ApprovedApproved three days prior to PDUFA
SNY55.7157.4247.06LemtradaRelapsing forms of multiple sclerosis.CRLCRL 29/12/13
UTHR132.71136.9377.22Oral treprostinilPulmonary arterial hypertension (PAH)2/16/2014ApprovedApproved Dec 20 2013. Early approval following previous extension
THRX17.7634.2617.43UMEC/VI (62.5/25mcg and 125/25mcg doses) ANORO ELLIPTAChronic Obstructive Pulmonary Disease (COPD)12/18/2013ApprovedApproved Dec 18 2013
JNJ106.54108.7785.50Canagliflozin and immediate-release metforminAdults with type 2 diabetesCRL
GILD107.51110.6458.81Sovaldi (Sofosbuvir)HCV6/12/2013Approved
AUXL30.4432.8916.36XIAFLEXPeyronie’s6/12/2013ApprovedApproved Dec 6 2013
PCYC120.54154.8982.51Ibrutinib 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
ZGNX1.195.191.14Zohydro ERModerate to severe painApprovedApproved Oct 25 2013. Decision was delayed by several months
AGN179.70181.9488.34JUVÉDERM VOLUMA XCAge-related volume loss in the cheek area in adults over the age of 21ApprovedApproved Oct 23 2013
ALIOF116.08129.2566.51Macitentan (Opsumit)Pulmonary arterial hypertension10/18/2013ApprovedApproved Oct 18 2013
ALIM5.338.441.65IluvienDiabetic macular edema10/17/2013CRLCRL Nov 2011. Second CRL Oct 17 2013. Adcom meeting Jan 27 2014
PSDV4.305.602.28IluvienDiabetic macular edema10/17/2013CRLCRL Nov 2011. Second CRL Oct 17 2013. Adcom meeting Jan 27 2014
ATRS1.875.151.86OTREXUPRheumatoid arthritis (RA)10/14/2013ApprovedApproved Oct 14 2013
DCTH2.0010.561.90CHEMOSAT systemCancer - unresectable metastatic ocular melanoma in the liver9/13/2013CRL CRL Sept 13 2013
CELG95.6496.5066.85ABRAXANEMetastatic pancreatic cancer9/21/2013ApprovedApproved Sep 6 2013
QRXPY0.084.350.08MOXDUOModerate to severe acute pain8/26/2013CRLCRL Aug 2013. Expects to resubmit 4Q 2013. Expects Adcom meeting
SUPN8.8411.475.84Trokendi XR SPN-538EpilepsyApprovedApproved Aug 19 2013
JNJ106.54108.7785.50SIMPONI ARIARheumatoid ArthritisApprovedApproved Jul 18 2013
MRK59.4161.3344.62Suvorexant tabletsInsomniaCRLAdcom May 22 2013. 13-3 positive vote. CRL received Jul 1 2013
GSK46.2956.7346.01Dolutegravir - ViiV HealthcareHIV8/17/2013ApprovedPDUFA Aug 12 under priority review.
JNJ106.54108.7785.50XARELTO (rivaroxaban)Stent Thrombosis in Patients with Acute Coronary SyndromeCRLCRL issued Jun 28 2013
THRX17.7634.2617.43VIBATIV (telavancin hydrochloride) for injectionHospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP)ApprovedApproved Jun 21 2013
AMGN140.07144.46105.76XGEVACancer - Giant Cell Tumor Of BoneApprovedApproved 6/13/13
AVEO1.162.351.00TivozanibCancer - advanced renal cell carcinoma7/28/2013CRLNegative 1-13 vote at Adcom meeting May 2 2013.Early CRL Jun 10 2013
CELG95.6496.5066.85REVLIMIDCancer - relapsed/refractory mantle cell lymphomaApproved Approved Jun 5 2013 under priority review
FLML14.5815.965.30Bloxiverz (neostigmine methylsulfate)Reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery5/31/2013ApprovedApproved Jun 3 2013
DEPO15.2215.516.95SEFELSAHot flashes5/31/2013CRLCRL May 31 2013
ENDP69.5282.1643.12AVEED (testosterone undecanoate) intramuscular injectionMen diagnosed with hypogonadismCRLCRL issued May 30 2013. Expects to respond 3Q 2013
GSK46.2956.7346.01DabrafenibCancer - melanoma6/3/2013Approved Approved May 29 2013
GSK46.2956.7346.01TrametinibCancer - melanoma6/3/2013ApprovedApproved May 29 2013
VRX130.26153.10102.60EfinaconazoleOnychomycosis5/24/2013CRLCRL May 28 2013
JNJ106.54108.7785.50SIMPONI (golimumab) ulcerative colitis (UC)ApprovedApproved May 16
THRX17.7634.2617.43BREO ELLIPTAChronic Obstructive Pulmonary Disease (COPD)5/12/2013ApprovedApproved May 10 2013
GSK46.2956.7346.01BREO ELLIPTAChronic Obstructive Pulmonary Disease (COPD)5/12/2013ApprovedApproved May 10 2013
BMY51.7157.4945.70SUSTIVA® (efavirenz)HIV-1ApprovedsNDA approved May 3 2013
MRK59.4161.3344.62LIPTRUZET (ezetimibe and atorvastatin)LDL CholesterolApprovedApproved May 3 2013
SHPG260.67264.98113.59Vyvanse® (lisdexamfetamine dimesylate) Children and Adolescents with ADHD5/1/2013ApprovedApproved May 1 2013
TTNP0.571.270.51ProbuphineOpioid dependence4/30/2013CRLCRL issued midnight Apr 30
RPTP10.1517.727.12DR CysteamineCystinosis4/30/2013ApprovedApproved Apr 30, 2013.
GILD107.51110.6458.81ElvitegravirHIV4/27/2013CRLCRL Apr 29 2013
GILD107.51110.6458.81CobicistatHIV4/28/2013CRLCRL Apr 29 2013
SCMP6.6511.005.80Amitiza/ LubiprostoneOpioid-induced bowel dysfunction4/24/2013ApprovedApproved Apr 23 2013
NVS93.5695.5072.77Simbrinza(TM) SuspensionGlaucomaApprovedApproved Apr 19 2013
JNJ106.54108.7785.50InvokanaType 2 diabetes3/31/2013ApprovedApproved Mar 29 2013
APPA8.77APF530Prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV)3/27/2013CRLCRL Mar 28 2013. Changed ticker to HRTX
UTHR132.71136.9377.22Treprostinil diolamine extended release tablets (oral treprostinil)Pulmonary arterial hypertension3/31/2013CRLCRL Mar 25, 6 days early
NAVB1.332.751.11LymphoseekLymphatic-tissue tracing agent4/30/2013Approved Approved Mar 13 2013. 7 weeks early.
JNJ106.54108.7785.50XARELTOReduction 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.
DVAX1.462.141.10HEPLISAVHepatitis B2/24/2013CRLCRL Feb 25 2013. Hopes to meet with FDA by mid April to discuss CRL
IMGN11.1718.1910.28KadcylaCancer - 2nd-line HER2+ Metastatic Breast Cancer2/26/2013ApprovedApproved Feb 22 2013 - under priority review
NVS93.5695.5072.77Zortress (everolimus)Prevent organ rejection in adult liver transplant patientsApprovedApproved Feb 15 2013
CELG95.6496.5066.85PomalystCancer - Multiple Myeloma2/10/2013ApprovedApproved Feb 8 2013
HEB0.320.550.19Ampligen CFS2/4/2013CRLCRL Feb 4 2012. Resubmission. More trials required. Intends to appeal
HPTX25.8532.9818.97RavictiUrea cycle disorders1/22/2013ApprovedApproved Feb 1 2013. FDA had advised company of delay
FURX104.77121.9732.05AlogliptinDiabetes - Type 21/27/2013Approved NDA resubmitted July 27 2012, following CRL. Approved Jan 25 2013
IPXL24.3431.0419.39IPX066Parkinson'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.
AEGR34.61101.0026.25LomitapideHomozygous familial hypercholesterolemia (HoFH)1/6/2013ApprovedEarly approval Dec 24 2012
ALXA2.375.932.28Staccato loxapine (ADASUVE). Schizophrenia12/21/2012Approved
NPSP27.0339.6821.60GattexShort bowel syndrome or SBS12/30/2012ApprovedPDUFA date was Dec 30 2012. Early approval on Dec 21
ARIA5.7819.252.15Oral ponatinibCancer - chronic myeloid leukemia, acute lymphoblastic leukemia3/27/2013ApprovedPDUFA March 27 2013. Early approval Dec 14 2012 under priority review
EXEL1.598.411.51CabozantinibCancer - Medullary thyroid 11/29/2012ApprovedApproved Nov 29 2012 under priority review
LGND47.6180.4240.81Promacta/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
SUPN8.8411.475.84OxtellarEpilepsy10/22/2012Approved
NAVB1.332.751.11LymphoseekLymphatic-tissue tracing agent9/10/2012CRL3rd party manufacturing deficiencies cited
MDVN100.25103.8848.15MDV3100Cancer - prostate 2nd line8/31/2012Approved Early approval decision by 3mths approx. Was under priority review
TLON0.161.830.13Marqibo2nd line adult Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL)8/12/2012Approved Approved 8/9/2012
HALO9.4518.186.88HyQPrimary immunodeficiency diseaseCRL
PGNX5.257.453.10Subcutaneous RELISTORchronic pain7/27/2012CRLPrice shown is for PGNX. Partnered with SLXP
AMRN1.137.391.07Vascepa Elevated triglyceride levels7/26/2012Approved
HZNP12.1318.303.21LODOTRA (RAYOS)Rheumetoid Arthritis7/26/2012Approved
ONXXCarfilzomibMultiple myeloma7/20/2012ApprovedAcquired by Amgen.
VVUS4.0211.643.32QnexaObesity7/18/2012Approved
ARNA4.257.973.82LorcaserinObesity6/27/2012Approved
QRX0.030.950.03MOXDUOModerate to severe acute pain6/26/2012CRL
RGEN20.1024.689.89RG1068Detection of pancreatic duct abnormalities6/22/2012CRL
XNPT5.497.203.14HorizantPostherpetic Neuralgia6/9/2012Approved
ARIA5.7819.252.15RidaforolimusSoft tissue or bone sarcoma6/6/2012CRL
EBS21.6928.4817.31BioThraxAnthrax Vaccine5/17/2012ApprovedApproved May 17 2012
TLON0.161.830.13MarqiboPhiladelphia chromosome-negative acute lymphoblastic leukemia 5/13/2012Extended
ALXA2.375.932.28ADASUVESchizophrenia5/3/2012CRL
PLX2.385.302.35Taliglucerase alfa Gaucher disease5/1/2012Approved
VVUS4.0211.643.32AvanafilErectile dysfunction4/29/2012Approved
PGNX5.257.453.10Subcutaneous RELISTORChronic pain4/27/2012ExtendedPrice shown is for PGNX
FURX104.77121.9732.05AlogliptinDiabetes - Type 24/25/2012CRL
VVUS4.0211.643.32QnexaObesity4/17/2012Extended
CHTPNORTHERA Neurogenic Orthostatic Hypotension3/28/2012CRLAcquired by Lundbeck
AFFY0.151.460.09PeginesatideAnemia in chronic renal failure (CRF)3/27/2012ApprovedBankrupt
MAPPLevadexMigraine3/26/2012CRLAcquired by Allergan
CRIS1.424.741.35VismodegibBasal Cell Carcinoma3/8/2012ApprovedEarly decision Jan 30,2012
NGSX0.010.020.00QutenzaNeuropathic pain associated with HIV-associated peripheral neuropathy (HIV-PN)3/7/2012CRL
DSCO1.783.051.51Surfaxin Respiratory Distress Syndrome - Severe3/6/2012Approved
ASTXDacogenAcute myeloid leukemia3/6/2012CRLAcquired by Otsuka
CBRX5.937.515.59Progesterone vaginal gelReduction of risk of preterm birth2/26/2012CRL
CORT2.774.491.57Corlux - KorlymCushing's Syndrome2/17/2012Approved
BPAXBio-T-GelMale hypogonadism2/14/2012ApprovedMerged. New ticker ANIP
ALXA2.375.932.28ADASUVESchizophrenia2/4/2012Extended 3months
AMLNBYDUREONType 2 diabetes1/28/2012ApprovedAcquired by Bristol-Myers Squibb
ALKS43.7554.2529.36BYDUREONType 2 diabetes1/28/2012Approved
PLX2.385.302.35Taliglucerase alfa Gaucher disease1/2/2012Extended 3 monthsInformed Dec 6 2011
NEOLSUBSYSCancer pain1/1/2012ApprovedNew ticker INSY
AIS1.87142.70128.00AnturolOveractive bladder12/8/2011ApprovedChanged ticker to ATRS
INCY50.5270.8633.01JakafiMyelofibrosis12/3/2011ApprovedApproved Nov 16 2011
TSPT1.993.901.85IntermezzoInsomnia11/27/2011Approved
SPPI8.2510.326.36Removal of the Bioscan Requirement for ZevalinNon-Hodgkin's lymphoma11/20/2011Approved
ALIM5.33ILUVIENDiabetic macular edema11/12/2011CRLEarly CRL. Price shown is for ALIM
IGXT0.481.180.44CPI-300Major Depressive Disorder11/10/2011Approved
PCRX99.16109.9445.68EXPARELPostsurgical pain10/28/2011Approved
SGEN38.3955.9932.35ADCETRISHodgkin lymphoma8/30/2011Approved
SGEN38.3955.9932.35ADCETRISAnaplastic large cell lymphoma8/30/2011Approved
PATHZelrixMigraine8/29/2011CRLAcquired by TEVA.
MSTX0.561.100.40ExelbineNSCLC8/9/2011CRLNew ticker MSTX. Formerly ANX
TSPT1.993.901.85IntermezzoInsomnia7/14/2011CRL
PTIE4.066.222.48REMOXYModerate to severe pain6/23/2011CRL
FCSC2.756.302.60LavivWrinkles6/22/2011Approved
ACUR0.792.230.68OxectaPain relief6/17/2011Approved
OPTRFidaxomicinCDI - diarrhea5/30/2011Approved
SPPI8.2510.326.36FUSILEVColorectal cancer4/29/2011Approved
XNPT5.497.203.14HorizantRestless Legs Syndrome4/6/2011Approved
HGSI0.00BENLYSTALupus3/10/2011Approved
PLX2.385.302.35Taliglucerase alfa Gaucher disease2/25/2011CRL
OREX4.527.824.32ContraveObesity1/31/2011CRL
DEPO15.2215.516.95GRALISEPostherpetic neuralgia - shingles1/30/2011Approved
MNKD6.0811.483.80AfrezzaInsulin1/26/2011CRLEarly CRL
CLDA#N/AViibrydMajor depressive disorder1/23/2011ApprovedAcquired by Forest Laboratories (FRX)
PSDV/ALIM#N/AILUVIENDiabetic macular edema12/29/2010CRLEarly CRL. Price shown is for ALIM
CADX0.00OFIRMEVPain and fever11/4/2010Approved
BIOD1.653.711.61VIAjectDiabetes10/30/2010CRL
AVNR11.9513.092.62NUEDEXTAPseudobulbar affect10/30/2010Approved
VVUS4.0211.643.32QnexaObesity10/28/2010CRL
ALKS/AMLN#N/ABYDUREONType 2 diabetes10/22/2010CRL
ISTA0.00BROMDAYPostoperative inflammation and reduction of ocular pain10/16/2010ApprovedAcquired by Bausch + Lomb
QCOR0.0097.8047.71ActharInfantile spasms10/15/2010Approved
ALXA2.375.932.28ADASUVESchizophrenia10/11/2010CRL
JAZZ162.16176.6080.40JZP-6Fibromyalgia10/11/2010CRL
HGSIZALBINHepatitis C10/5/2010CRLAcquired by GSK
PGNX5.257.453.10RelistorOpioid-induced constipation (OIC)9/29/2010Approved
SVNTKRYSTEXXAGout9/14/2010ApprovedBankrupt
QCOR0.0097.8047.71ActharInfantile spasms6/11/2010Extended 4 months
POZN7.619.905.35VIMOVOGastric ulcers4/30/2010Approved
ITMN73.8974.2410.95EsbrietIdiopathic pulmonary fibrosis 4/5/2010CRL
SLXP155.78172.9865.93XIFAXANHepatic encephalopathy3/24/2010Approved
CTIC2.494.251.49PixuvriNon-Hodgkin's lymphoma3/23/2010CRL
SOMX3.005.441.29SilenorInsomnia3/19/2010Approved
APPA8.77APF530Chemotherapy-induced nausea and vomiting3/18/2010CRLChanged ticker to HRTX
SUPG0.00DacogenMyelodysplastic syndromes3/8/2010ApprovedChanged ticker to ASTX
ALKS43.75BYDUREONType 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
DDSS#N/AOleptroMajor depressive disorder2/11/2010ApprovedBankrupt
XNPT5.497.203.14HorizantRestless Legs Syndrome2/9/2010CRL
PLX2.385.302.35Taliglucerase alfa Gaucher disease2/9/2010Extended
ACOR35.6939.9427.51AMPYRAImprove walking in patients with multiple sclerosis1/22/2010Approved
MNKD6.0811.483.80AFREZZADiabetes1/16/2010CRLFDA responded 15 Mar 2010
FCSC2.756.302.60LavivWrinkles1/4/2010CRLEarly CRL
VIONOnriginAcute myeloid leukemia12/12/2009CRLBankrupt
SOMX3.005.441.29SilenorInsomnia12/4/2009CRL
SNTSZEGERIDGERD12/4/2009ApprovedAcquired by Salix.
DYAX10.5111.016.05KALBITORHereditary angioedema 12/1/2009Approved
NGSX0.020.00QutenzaPostherpetic neuralgia11/16/2009Approved
CADXOFIRMEVMild to moderate pain11/13/2009Approved
NRIFF4.445.201.54PennsaidOsteoarthritis of the knee11/4/2009Approved
TSPT1.993.901.85IntermezzoInsomnia11/2/2009CRL
GTXI0.732.350.69ToremifeneReduce fractures in men with prostate cancer10/30/2009CRL
SPPI8.2510.326.36FUSILEVColorectal cancer10/8/2009CRL
ALTH#N/A#N/AFOLOTYNPeripheral T-cell lymphoma9/24/2009Approved
ISTABepreveAllergic conjunctivitis9/14/2009ApprovedAcquired by Bausch + Lomb
SPPI8.2510.326.36ZEVALINNon-Hodgkin's Lymphoma 9/7/2009Approved
NGSX0.010.020.00QutenzaPostherpetic neuralgia8/17/2009Extended 3 months
SVNTKRYSTEXXAGout8/3/2009CRLBankrupt
DDSS#N/AOleptroMajor depressive disorder7/20/2009CRLBankrupt
ZGNX1.195.191.14SumavelMigraine7/15/2009Approved
ARDM9.82SumavelMigraine7/15/2009Approved
SPPI8.2510.326.36ZEVALINNHL7/2/2009CRL
HEB0.320.550.19AmpligenChronic 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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