FDA Historical Calendar

TickerCurrent price52 hi52 loProductIndicationPDUFA dateDecisionNotes
MDCO26.0941.2822.71OritavancinABSSSI8/6/2014ApprovedApproved under priority review
PCYC120.24154.8982.51Ibrutinib Deletion 17pApprovedApproved July 29 2014
PCYC120.24154.8982.51Ibrutinib Cancer - Refractory Chronic Lymphocytic Leukemia/Small Cell Lymphocytic Lymphoma (CLL/SLL)ApprovedApproved July 29 2014
ACRX6.9913.646.04ZalvisoPost-operative pain following open abdominal surgery and hip or knee replacement surgery7/27/2014CRLCRL Jul 26 2014
EGRX12.6316.449.16RyanodexMalignant hyperthermia7/22/2014Approved
SLXP157.64162.3864.93RUCONESTHereditary angioedema (HAE)7/16/2014Approved Partnered with Dutch company Pharming
ANAC22.5223.079.75TavaboroleOnychomycosis7/29/2014ApprovedApproved July 8 2014
SPPI8.1510.326.36BelinostatCancer - Peripheral T-Cell Lymphoma8/9/2014ApprovedApproved two months early under accelerated approval program.
EGRX12.6316.449.16EP-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
FLML14.7215.965.30VAZCULEP (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
NPSP29.3739.6821.60GATTEXShort Bowel Syndrome 7/28/2014ApprovedsNDA - seeking additions to label
MNKD7.3411.483.80AFREZZA Type 1/2 diabetes7/15/2014ApprovedApproved June 27 2014
CBST68.5382.1258.50Tedizolid phosphateAcute bacterial skin and skin structure infections (ABSSSI)6/22/2014Approved Approved June 20 2014
NAVB1.283.081.11LymphoseekHead and Neck Cancer6/16/2014ApprovedApproved Jun 13 2014
BDSI14.6614.954.16BEMA Buprenorphine/Naloxone (BNX) - BUNAVAILOpioid dependence6/7/2014ApprovedApproved June 7 2014
OMER14.0918.804.95OmidriaCataract surgery6/1/2014Approved Approved June 2 2014
TRLPF0.420.850.34Loading...PDUFA5/28/2014PDUFA date February 28 2014, extended to May 28 2014, for bioadhesive intranasal gel testosterone product (CompleoTRT)
QRXPY0.145.100.11MOXDUOModerate to severe acute pain5/25/2014CRL
DRTX16.7718.178.01DalbavancinAcute bacterial skin and skin structure infections (ABSSSI)5/26/2014ApprovedApproved May 23 2014
FLML14.7215.965.30??????4/28/2014CRLCRL April 28 2014
MDCO26.0941.2822.71CangrelorReduction of thrombotic cardiovascular events including stent thrombosis in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI).4/30/2014CRLCRL April 30 2014
POZN8.379.905.01PA32540 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
BMY50.7757.4941.32Eliquis To Reduce The Risk Of Blood Clots Following Hip Or Knee Replacement Surgery3/15/2014ApprovedApproved March 14 2014
PFE29.2132.9627.76EliquisTo Reduce The Risk Of Blood Clots Following Hip Or Knee Replacement Surgery3/15/2014ApprovedApproved March 14 2014
ENDP65.2382.1638.58AVEED (testosterone undecanoate) intramuscular injectionMen diagnosed with hypogonadism3/28/2014ApprovedApproved March 6 2014
AZN73.7482.6848.53MetreleptinLipodystrophy2/27/2014ApprovedApproved Feb 25 2014
BMY50.7757.4941.32MetreleptinLipodystrophy2/27/2014ApprovedApproved Feb 25 2014
CHTPNORTHERA Neurogenic Orthostatic HypotensionApprovedApprovedApproved one day late due to snow. Acquired by Lundbeck
BMRN71.5584.2555.04Vimizim (GALNS)(MPS IVA) Morquio A Syndrome2/28/2014Approved Early approval. Was under priority review
DRRX1.582.691.07PosidurPost-operative pain relief 2/12/2014CRL
PCYC120.24154.8982.51Ibrutinib Cancer - Chronic Lymphocytic Leukemia Who Have Received at Least One Prior Therapy2/28/2014ApprovedApproved Feb 12 2014
VNDA12.9519.255.70HETLIOZ (tasimelteon)Non-24-Hour Sleep-Wake Disorder1/31/2014Approved
VRX117.10153.1095.28Retin-A Micro (tretinoin) Gel microsphere 0.08% Acne vulgarisApprovedsNDA
AMAG22.0028.4216.49FerahemeIron 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
NRIFF3.115.201.38Pennsaid 2%Pain of osteoarthritis of the knee2/7/2014ApprovedApproved Jan 17 2014
AZN73.7482.6848.53FARXIGA (dapagliflozin) tablets Adult patients with type 2 diabetesApproved
BMY50.7757.4941.32FARXIGA (dapagliflozin) tabletsAdult patients with type 2 diabetesApproved
GSK48.2656.7346.01Mekinist (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
MRK60.2060.4044.62ISENTRESS for oral suspensionHIV-1 infected infants and childrenApproved
AZN73.7482.6848.53Forxiga (dapagliflozin)Type 2 diabetes1/11/2014ApprovedApproved three days prior to PDUFA
BMY50.7757.4941.32Forxiga (dapagliflozin)Type 2 diabetes1/11/2014ApprovedApproved three days prior to PDUFA
SNY54.7954.9546.95LemtradaRelapsing forms of multiple sclerosis.CRLCRL 29/12/13
UTHR94.51116.6570.34Oral treprostinilPulmonary arterial hypertension (PAH)2/16/2014ApprovedApproved Dec 20 2013. Early approval following previous extension
THRX23.2234.5520.25UMEC/VI (62.5/25mcg and 125/25mcg doses) ANORO ELLIPTAChronic Obstructive Pulmonary Disease (COPD)12/18/2013ApprovedApproved Dec 18 2013
JNJ103.44106.7485.50Canagliflozin and immediate-release metforminAdults with type 2 diabetesCRL
GILD106.27108.7258.50Sovaldi (Sofosbuvir)HCV6/12/2013Approved
AUXL18.6332.8916.36XIAFLEXPeyronie’s6/12/2013ApprovedApproved Dec 6 2013
PCYC120.24154.8982.51Ibrutinib 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
ZGNX1.345.191.18Zohydro ERModerate to severe painApprovedApproved Oct 25 2013. Decision was delayed by several months
AGN163.97174.4986.95JUVÉDERM VOLUMA XCAge-related volume loss in the cheek area in adults over the age of 21ApprovedApproved Oct 23 2013
ALIOF123.63129.2566.51Macitentan (Opsumit)Pulmonary arterial hypertension10/18/2013ApprovedApproved Oct 18 2013
ALIM5.658.441.65IluvienDiabetic macular edema10/17/2013CRLCRL Nov 2011. Second CRL Oct 17 2013. Adcom meeting Jan 27 2014
PSDV4.765.602.28IluvienDiabetic macular edema10/17/2013CRLCRL Nov 2011. Second CRL Oct 17 2013. Adcom meeting Jan 27 2014
ATRS2.125.151.87OTREXUPRheumatoid arthritis (RA)10/14/2013ApprovedApproved Oct 14 2013
DCTH2.3310.561.90CHEMOSAT systemCancer - unresectable metastatic ocular melanoma in the liver9/13/2013CRL CRL Sept 13 2013
CELG95.6595.8466.85ABRAXANEMetastatic pancreatic cancer9/21/2013ApprovedApproved Sep 6 2013
QRXPY0.145.100.11MOXDUOModerate to severe acute pain8/26/2013CRLCRL Aug 2013. Expects to resubmit 4Q 2013. Expects Adcom meeting
SUPN8.9611.475.84Trokendi XR SPN-538EpilepsyApprovedApproved Aug 19 2013
JNJ103.44106.7485.50SIMPONI ARIARheumatoid ArthritisApprovedApproved Jul 18 2013
MRK60.2060.4044.62Suvorexant tabletsInsomniaCRLAdcom May 22 2013. 13-3 positive vote. CRL received Jul 1 2013
GSK48.2656.7346.01Dolutegravir - ViiV HealthcareHIV8/17/2013ApprovedPDUFA Aug 12 under priority review.
JNJ103.44106.7485.50XARELTO (rivaroxaban)Stent Thrombosis in Patients with Acute Coronary SyndromeCRLCRL issued Jun 28 2013
THRX23.2234.5520.25VIBATIV (telavancin hydrochloride) for injectionHospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP)ApprovedApproved Jun 21 2013
AMGN137.27137.67105.76XGEVACancer - Giant Cell Tumor Of BoneApprovedApproved 6/13/13
AVEO1.372.361.00TivozanibCancer - advanced renal cell carcinoma7/28/2013CRLNegative 1-13 vote at Adcom meeting May 2 2013.Early CRL Jun 10 2013
CELG95.6595.8466.85REVLIMIDCancer - relapsed/refractory mantle cell lymphomaApproved Approved Jun 5 2013 under priority review
FLML14.7215.965.30Bloxiverz (neostigmine methylsulfate)Reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery5/31/2013ApprovedApproved Jun 3 2013
DEPO15.1015.396.95SEFELSAHot flashes5/31/2013CRLCRL May 31 2013
ENDP65.2382.1638.58AVEED (testosterone undecanoate) intramuscular injectionMen diagnosed with hypogonadismCRLCRL issued May 30 2013. Expects to respond 3Q 2013
GSK48.2656.7346.01DabrafenibCancer - melanoma6/3/2013Approved Approved May 29 2013
GSK48.2656.7346.01TrametinibCancer - melanoma6/3/2013ApprovedApproved May 29 2013
VRX117.10153.1095.28EfinaconazoleOnychomycosis5/24/2013CRLCRL May 28 2013
JNJ103.44106.7485.50SIMPONI (golimumab) ulcerative colitis (UC)ApprovedApproved May 16
THRX23.2234.5520.25BREO ELLIPTAChronic Obstructive Pulmonary Disease (COPD)5/12/2013ApprovedApproved May 10 2013
GSK48.2656.7346.01BREO ELLIPTAChronic Obstructive Pulmonary Disease (COPD)5/12/2013ApprovedApproved May 10 2013
BMY50.7757.4941.32SUSTIVA® (efavirenz)HIV-1ApprovedsNDA approved May 3 2013
MRK60.2060.4044.62LIPTRUZET (ezetimibe and atorvastatin)LDL CholesterolApprovedApproved May 3 2013
SHPG244.50258.55109.82Vyvanse® (lisdexamfetamine dimesylate) Children and Adolescents with ADHD5/1/2013ApprovedApproved May 1 2013
TTNP0.661.270.53ProbuphineOpioid dependence4/30/2013CRLCRL issued midnight Apr 30
RPTP11.4617.727.12DR CysteamineCystinosis4/30/2013ApprovedApproved Apr 30, 2013.
GILD106.27108.7258.50ElvitegravirHIV4/27/2013CRLCRL Apr 29 2013
GILD106.27108.7258.50CobicistatHIV4/28/2013CRLCRL Apr 29 2013
SCMP6.9511.005.40Amitiza/ LubiprostoneOpioid-induced bowel dysfunction4/24/2013ApprovedApproved Apr 23 2013
NVS89.7191.6672.24Simbrinza(TM) SuspensionGlaucomaApprovedApproved Apr 19 2013
JNJ103.44106.7485.50InvokanaType 2 diabetes3/31/2013ApprovedApproved Mar 29 2013
APPA9.79APF530Prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV)3/27/2013CRLCRL Mar 28 2013. Changed ticker to HRTX
UTHR94.51116.6570.34Treprostinil diolamine extended release tablets (oral treprostinil)Pulmonary arterial hypertension3/31/2013CRLCRL Mar 25, 6 days early
NAVB1.283.081.11LymphoseekLymphatic-tissue tracing agent4/30/2013Approved Approved Mar 13 2013. 7 weeks early.
JNJ103.44106.7485.50XARELTOReduction 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.
DVAX1.452.141.10HEPLISAVHepatitis B2/24/2013CRLCRL Feb 25 2013. Hopes to meet with FDA by mid April to discuss CRL
IMGN12.1818.3410.28KadcylaCancer - 2nd-line HER2+ Metastatic Breast Cancer2/26/2013ApprovedApproved Feb 22 2013 - under priority review
NVS89.7191.6672.24Zortress (everolimus)Prevent organ rejection in adult liver transplant patientsApprovedApproved Feb 15 2013
CELG95.6595.8466.85PomalystCancer - Multiple Myeloma2/10/2013ApprovedApproved Feb 8 2013
HEB0.280.550.19Ampligen CFS2/4/2013CRLCRL Feb 4 2012. Resubmission. More trials required. Intends to appeal
HPTX26.0032.9818.97RavictiUrea 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
IPXL24.9131.0419.39IPX066Parkinson'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.
AEGR30.97101.0026.25LomitapideHomozygous familial hypercholesterolemia (HoFH)1/6/2013ApprovedEarly approval Dec 24 2012
ALXA3.515.933.41Staccato loxapine (ADASUVE). Schizophrenia12/21/2012Approved
NPSP29.3739.6821.60GattexShort bowel syndrome or SBS12/30/2012ApprovedPDUFA date was Dec 30 2012. Early approval on Dec 21
ARIA6.5023.002.15Oral ponatinibCancer - chronic myeloid leukemia, acute lymphoblastic leukemia3/27/2013ApprovedPDUFA March 27 2013. Early approval Dec 14 2012 under priority review
EXEL4.158.413.02CabozantinibCancer - Medullary thyroid 11/29/2012ApprovedApproved Nov 29 2012 under priority review
LGND51.8580.4239.75Promacta/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
SUPN8.9611.475.84OxtellarEpilepsy10/22/2012Approved
NAVB1.283.081.11LymphoseekLymphatic-tissue tracing agent9/10/2012CRL3rd party manufacturing deficiencies cited
MDVN88.6289.2448.15MDV3100Cancer - 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
HALO9.8918.186.88HyQPrimary immunodeficiency diseaseCRL
PGNX5.447.453.10Subcutaneous RELISTORchronic pain7/27/2012CRLPrice shown is for PGNX. Partnered with SLXP
AMRN1.907.401.28Vascepa Elevated triglyceride levels7/26/2012Approved
HZNP9.7818.302.46LODOTRA (RAYOS)Rheumetoid Arthritis7/26/2012Approved
ONXXCarfilzomibMultiple myeloma7/20/2012ApprovedAcquired by Amgen.
VVUS4.2812.954.06QnexaObesity7/18/2012Approved
ARNA4.257.974.05LorcaserinObesity6/27/2012Approved
QRX0.031.100.03MOXDUOModerate to severe acute pain6/26/2012CRL
RGEN20.6624.689.41RG1068Detection of pancreatic duct abnormalities6/22/2012CRL
XNPT5.307.203.14HorizantPostherpetic Neuralgia6/9/2012Approved
ARIA6.5023.002.15RidaforolimusSoft tissue or bone sarcoma6/6/2012CRL
EBS24.8228.4817.14BioThraxAnthrax Vaccine5/17/2012ApprovedApproved May 17 2012
TLON0.161.830.13MarqiboPhiladelphia chromosome-negative acute lymphoblastic leukemia 5/13/2012Extended
ALXA3.515.933.41ADASUVESchizophrenia5/3/2012CRL
PLX2.455.602.35Taliglucerase alfa Gaucher disease5/1/2012Approved
VVUS4.2812.954.06AvanafilErectile dysfunction4/29/2012Approved
PGNX5.447.453.10Subcutaneous RELISTORChronic pain4/27/2012ExtendedPrice shown is for PGNX
FURX104.77121.9732.05AlogliptinDiabetes - Type 24/25/2012CRL
VVUS4.2812.954.06QnexaObesity4/17/2012Extended
CHTPNORTHERA Neurogenic Orthostatic Hypotension3/28/2012CRLAcquired by Lundbeck
AFFY0.282.030.09PeginesatideAnemia in chronic renal failure (CRF)3/27/2012ApprovedBankrupt
MAPPLevadexMigraine3/26/2012CRLAcquired by Allergan
CRIS1.594.741.53VismodegibBasal Cell Carcinoma3/8/2012ApprovedEarly decision Jan 30,2012
NGSX0.010.020.00QutenzaNeuropathic pain associated with HIV-associated peripheral neuropathy (HIV-PN)3/7/2012CRL
DSCO1.793.051.51Surfaxin Respiratory Distress Syndrome - Severe3/6/2012Approved
ASTXDacogenAcute myeloid leukemia3/6/2012CRLAcquired by Otsuka
CBRX6.018.375.59Progesterone vaginal gelReduction of risk of preterm birth2/26/2012CRL
CORT2.804.491.56Corlux - KorlymCushing's Syndrome2/17/2012Approved
BPAXBio-T-GelMale hypogonadism2/14/2012ApprovedMerged. New ticker ANIP
ALXA3.515.933.41ADASUVESchizophrenia2/4/2012Extended 3months
AMLNBYDUREONType 2 diabetes1/28/2012ApprovedAcquired by Bristol-Myers Squibb
ALKS45.0754.2529.36BYDUREONType 2 diabetes1/28/2012Approved
PLX2.455.602.35Taliglucerase alfa Gaucher disease1/2/2012Extended 3 monthsInformed Dec 6 2011
NEOLSUBSYSCancer pain1/1/2012ApprovedNew ticker INSY
AIS2.12142.70128.00AnturolOveractive bladder12/8/2011ApprovedChanged ticker to ATRS
INCY55.1870.8633.01JakafiMyelofibrosis12/3/2011ApprovedApproved Nov 16 2011
TSPT2.173.901.85IntermezzoInsomnia11/27/2011Approved
SPPI8.1510.326.36Removal of the Bioscan Requirement for ZevalinNon-Hodgkin's lymphoma11/20/2011Approved
ALIM5.65ILUVIENDiabetic macular edema11/12/2011CRLEarly CRL. Price shown is for ALIM
IGXT0.551.180.44CPI-300Major Depressive Disorder11/10/2011Approved
PCRX107.71108.5035.98EXPARELPostsurgical pain10/28/2011Approved
SGEN44.0955.9932.35ADCETRISHodgkin lymphoma8/30/2011Approved
SGEN44.0955.9932.35ADCETRISAnaplastic large cell lymphoma8/30/2011Approved
PATHZelrixMigraine8/29/2011CRLAcquired by TEVA.
MSTX0.611.100.40ExelbineNSCLC8/9/2011CRLNew ticker MSTX. Formerly ANX
TSPT2.173.901.85IntermezzoInsomnia7/14/2011CRL
PTIE4.316.222.46REMOXYModerate to severe pain6/23/2011CRL
FCSC3.096.302.70LavivWrinkles6/22/2011Approved
ACUR0.922.230.81OxectaPain relief6/17/2011Approved
OPTRFidaxomicinCDI - diarrhea5/30/2011Approved
SPPI8.1510.326.36FUSILEVColorectal cancer4/29/2011Approved
XNPT5.307.203.14HorizantRestless Legs Syndrome4/6/2011Approved
HGSI0.00BENLYSTALupus3/10/2011Approved
PLX2.455.602.35Taliglucerase alfa Gaucher disease2/25/2011CRL
OREX5.897.824.59ContraveObesity1/31/2011CRL
DEPO15.1015.396.95GRALISEPostherpetic neuralgia - shingles1/30/2011Approved
MNKD7.3411.483.80AfrezzaInsulin1/26/2011CRLEarly 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
BIOD1.925.271.83VIAjectDiabetes10/30/2010CRL
AVNR6.106.242.62NUEDEXTAPseudobulbar affect10/30/2010Approved
VVUS4.2812.954.06QnexaObesity10/28/2010CRL
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
ALXA3.515.933.41ADASUVESchizophrenia10/11/2010CRL
JAZZ163.56176.6080.40JZP-6Fibromyalgia10/11/2010CRL
HGSIZALBINHepatitis C10/5/2010CRLAcquired by GSK
PGNX5.447.453.10RelistorOpioid-induced constipation (OIC)9/29/2010Approved
SVNTKRYSTEXXAGout9/14/2010ApprovedBankrupt
QCOR0.0097.8047.71ActharInfantile spasms6/11/2010Extended 4 months
POZN8.379.905.01VIMOVOGastric ulcers4/30/2010Approved
ITMN72.9873.1810.95EsbrietIdiopathic pulmonary fibrosis 4/5/2010CRL
SLXP157.64162.3864.93XIFAXANHepatic encephalopathy3/24/2010Approved
CTIC2.554.251.07PixuvriNon-Hodgkin's lymphoma3/23/2010CRL
SOMX3.005.441.29SilenorInsomnia3/19/2010Approved
APPA9.79APF530Chemotherapy-induced nausea and vomiting3/18/2010CRLChanged ticker to HRTX
SUPG0.00DacogenMyelodysplastic syndromes3/8/2010ApprovedChanged ticker to ASTX
ALKS45.07BYDUREONType 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
DDSS0.13OleptroMajor depressive disorder2/11/2010ApprovedBankrupt
XNPT5.307.203.14HorizantRestless Legs Syndrome2/9/2010CRL
PLX2.455.602.35Taliglucerase alfa Gaucher disease2/9/2010Extended
ACOR32.7339.9427.51AMPYRAImprove walking in patients with multiple sclerosis1/22/2010Approved
MNKD7.3411.483.80AFREZZADiabetes1/16/2010CRLFDA responded 15 Mar 2010
FCSC3.096.302.70LavivWrinkles1/4/2010CRLEarly CRL
VIONOnriginAcute myeloid leukemia12/12/2009CRLBankrupt
SOMX3.005.441.29SilenorInsomnia12/4/2009CRL
SNTSZEGERIDGERD12/4/2009ApprovedAcquired by Salix.
DYAX10.1310.994.13KALBITORHereditary angioedema 12/1/2009Approved
NGSX0.020.00QutenzaPostherpetic neuralgia11/16/2009Approved
CADXOFIRMEVMild to moderate pain11/13/2009Approved
NRIFF3.115.201.38PennsaidOsteoarthritis of the knee11/4/2009Approved
TSPT2.173.901.85IntermezzoInsomnia11/2/2009CRL
GTXI0.972.360.81ToremifeneReduce fractures in men with prostate cancer10/30/2009CRL
SPPI8.1510.326.36FUSILEVColorectal cancer10/8/2009CRL
ALTH#N/A#N/AFOLOTYNPeripheral T-cell lymphoma9/24/2009Approved
ISTABepreveAllergic conjunctivitis9/14/2009ApprovedAcquired by Bausch + Lomb
SPPI8.1510.326.36ZEVALINNon-Hodgkin's Lymphoma 9/7/2009Approved
NGSX0.010.020.00QutenzaPostherpetic neuralgia8/17/2009Extended 3 months
SVNTKRYSTEXXAGout8/3/2009CRLBankrupt
DDSS0.13OleptroMajor depressive disorder7/20/2009CRLBankrupt
ZGNX1.345.191.18SumavelMigraine7/15/2009Approved
ARDM8.97SumavelMigraine7/15/2009Approved
SPPI8.1510.326.36ZEVALINNHL7/2/2009CRL
HEB0.280.550.19AmpligenChronic 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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