FDA Historical Calendar

TickerCurrent price52 hi52 loProductIndicationPDUFA dateDecisionNotes
MNTA17.0820.439.38Generic CopaxoneMultiple sclerosisApprovedFiled 2007. Approved mid April 16 2015
AMGN166.87173.14108.20CorlanorChronic Heart Failure5/27/2015ApprovedApproved April 15 2015
EBS30.1630.9619.31Anthrax Immune Globulin Intravenous (Human) [AIGIV] AnthraxApprovedApproved March 25 2015
VRTX128.94136.3362.40Vacaftor 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
BMY63.6869.2046.30OpdivoAdvanced Squamous Non-Small Cell Lung Cancer6/22/2015ApprovedApproved March 4 2015
PCRX83.47121.9563.56EXPARELSingle-dose injection femoral nerve block for total knee arthroplasty surgery3/5/2015CRLPDUFA CRL March 2 2015.
SNY52.1457.4243.57ToujeoType 1 and type 2 diabetesApprovedApproved Feb 26 2015
ESALY52.1580.4135.79Lenvatinib mesylate (lenvatinib)Differentiated thyroid cancer (DTC) 4/14/2015ApprovedApproved Feb 13 2015
PCYC258.02260.4782.51IMBRUVICAWaldenström’s Macroglobulinemia4/17/2015ApprovedApproved Jan 29, 2015
ZGNX1.603.101.07 Abuse deterrent formulations of Zohydro ERModerate to severe pain1/30/2015ApprovedApproved January 30 2015
RMTI11.0012.478.10Soluble Ferric PyrophosphateIron deficiency1/24/2015ApprovedApproved Jan 26 2015
NPSPNatparaHypoparathyroidism1/24/2015ApprovedApproved Jan 23 2015
IPXL51.2652.1022.12IPX066Parkinson's Approved Jan 8 2015
VRTX128.94136.3362.40KALYDECOCystic fibrosis (CF) ages 6 and older who have the R117H mutation12/30/2014ApprovedApproved Dec 28 2014
ADMS17.8721.6312.90NamzaricModerate to severe dementia of the Alzheimer's type.ApprovedApproved Dec 24 2014
BCRX9.7814.627.29Peramivir INFLUENZA ACUTE 12/23/2014ApprovedApproved Dec 22 2014
ENTA36.0552.5830.13VIEKIRA PAKHCV - genotype 112/21/2014ApprovedApproved December 19 2014
ABBV62.5970.7647.62VIEKIRA PAKHCV - genotype 112/21/2014ApprovedApproved December 19 2014
CBST101.94101.9958.50Ceftolozane/ tazobactam ZERBAXAComplicated Urinary Tract Infections (cUTI) and Complicated Intra-Abdominal Infections (cIAI)12/21/2014ApprovedApproved Dec 21 2014- priority review
POZN8.069.735.96PA32540 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
INCY102.76103.7442.74Jakafi Polycythemia Vera5/12/2014ApprovedApproved December 4 2014
AVNR16.9617.053.02AVP-825Acute migraine11/26/2014CRLCRL November 26 2014 - likely to resubmit 1H 2015
AEZS0.611.540.48Macimorelin AcetateAdult Growth Deficiency 11/5/2014CRL New trials required
PGNX6.527.843.10Subcutaneous RELISTORChronic pain9/29/2014Approved
SLXP172.81172.9886.00Subcutaneous RELISTORChronic pain9/29/2014Approved
ALIM5.106.544.12IluvienDiabetic macular edema9/26/2014Approved Sept 26 2014
PSDV4.064.943.31IluvienDiabetic macular edema9/26/2014Approved Sept 26 2014
AUXL36.4737.9217.10AvanafilErectile dysfunction9/20/2014ApprovedApproved 9/18/2014 - sNDA to change label allowing use 15 minutes before sexual activity.
VVUS2.425.952.28AvanafilErectile dysfunction9/20/2014ApprovedApproved 9/18/2014 - sNDA to change label allowing use 15 minutes before sexual activity.
NKTR12.1317.5310.32NaloxegolOpioid-induced constipation (OIC)9/16/2014ApprovedApproved Sept 16 2014
SLXP172.81172.9886.00Budesonide foamModerate ulcerative proctitis or proctosigmoiditis 9/15/2014Tentative approvalTentative approval granted September 15 2014 pending patent issues
HALO15.5216.556.88HYQVIASubcutaneous treatment for patients with primary immunodeficiency (PI)ApprovedApproved Sept 12 2014
OREX7.809.373.11ContraveObesity9/11/2014ApprovedApproved September 11 2014
MDVN130.79141.5855.25XTANDICancer - mCRPC who have not received chemotherapy9/17/2014ApprovedApproved Sept 10 2014
KERX12.2818.4810.85ZerenexHyperphosphatemia9/7/2014ApprovedApproved Sept 5 2014
LGND86.8587.1741.99PromactaAplastic AnemiaApproved Approved August 27 2014
MDCO29.1232.4419.92OritavancinABSSSI8/6/2014ApprovedApproved under priority review
PCYC258.02260.4782.51Ibrutinib Deletion 17pApprovedApproved July 29 2014
PCYC258.02260.4782.51Ibrutinib Cancer - Refractory Chronic Lymphocytic Leukemia/Small Cell Lymphocytic Lymphoma (CLL/SLL)ApprovedApproved July 29 2014
ACRX4.6211.653.58ZalvisoPost-operative pain following open abdominal surgery and hip or knee replacement surgery7/27/2014CRLCRL Jul 26 2014
EGRX55.1557.429.16RyanodexMalignant hyperthermia7/22/2014Approved
SLXP172.81172.9886.00RUCONESTHereditary angioedema (HAE)7/16/2014Approved Partnered with Dutch company Pharming
ANAC67.6868.0813.19TavaboroleOnychomycosis7/29/2014ApprovedApproved July 8 2014
SPPI6.099.275.58BelinostatCancer - Peripheral T-Cell Lymphoma8/9/2014ApprovedApproved two months early under accelerated approval program.
EGRX55.1557.429.16EP-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
FLML16.2619.509.30VAZCULEP (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
NPSP0.00#N/A#N/AGATTEXShort Bowel Syndrome 7/28/2014ApprovedsNDA - seeking additions to label
MNKD5.1811.484.45AFREZZA Type 1/2 diabetes7/15/2014ApprovedApproved June 27 2014
CBST101.94101.9958.50Tedizolid phosphateAcute bacterial skin and skin structure infections (ABSSSI)6/22/2014Approved Approved June 20 2014
NAVB1.552.020.97LymphoseekHead and Neck Cancer6/16/2014ApprovedApproved Jun 13 2014
BDSI10.0218.487.08BEMA Buprenorphine/Naloxone (BNX) - BUNAVAILOpioid dependence6/7/2014ApprovedApproved June 7 2014
OMER24.7027.649.76OmidriaCataract surgery6/1/2014Approved Approved June 2 2014
TRLPF0.600.850.29Loading...PDUFA5/28/2014PDUFA date February 28 2014, extended to May 28 2014, for bioadhesive intranasal gel testosterone product (CompleoTRT)
QRXPY0.053.410.04MOXDUOModerate to severe acute pain5/25/2014CRL
DRTX0.00#N/A#N/ADalbavancinAcute bacterial skin and skin structure infections (ABSSSI)5/26/2014ApprovedApproved May 23 2014
FLML16.2619.509.30??????4/28/2014CRLCRL April 28 2014
MDCO29.1232.4419.92CangrelorReduction of thrombotic cardiovascular events including stent thrombosis in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI).4/30/2014CRLCRL April 30 2014
POZN8.069.735.96PA32540 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
BMY63.6869.2046.30Eliquis To Reduce The Risk Of Blood Clots Following Hip Or Knee Replacement Surgery3/15/2014ApprovedApproved March 14 2014
PFE35.1935.5327.51EliquisTo Reduce The Risk Of Blood Clots Following Hip Or Knee Replacement Surgery3/15/2014ApprovedApproved March 14 2014
ENDP95.1196.5855.41AVEED (testosterone undecanoate) intramuscular injectionMen diagnosed with hypogonadism3/28/2014ApprovedApproved March 6 2014
AZN72.0382.6862.69MetreleptinLipodystrophy2/27/2014ApprovedApproved Feb 25 2014
BMY63.6869.2046.30MetreleptinLipodystrophy2/27/2014ApprovedApproved Feb 25 2014
CHTPNORTHERA Neurogenic Orthostatic HypotensionApprovedApprovedApproved one day late due to snow. Acquired by Lundbeck
BMRN121.65133.5455.36Vimizim (GALNS)(MPS IVA) Morquio A Syndrome2/28/2014Approved Early approval. Was under priority review
DRRX1.932.050.68PosidurPost-operative pain relief 2/12/2014CRL
PCYC258.02260.4782.51Ibrutinib Cancer - Chronic Lymphocytic Leukemia Who Have Received at Least One Prior Therapy2/28/2014ApprovedApproved Feb 12 2014
VNDA10.0916.508.34HETLIOZ (tasimelteon)Non-24-Hour Sleep-Wake Disorder1/31/2014Approved
VRX207.36211.57106.00Retin-A Micro (tretinoin) Gel microsphere 0.08% Acne vulgarisApprovedsNDA
AMAG58.1659.5517.14FerahemeIron 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
AZN72.0382.6862.69FARXIGA (dapagliflozin) tablets Adult patients with type 2 diabetesApproved
BMY63.6869.2046.30FARXIGA (dapagliflozin) tabletsAdult patients with type 2 diabetesApproved
GSK47.5856.4841.25Mekinist (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
MRK57.8463.6252.49ISENTRESS for oral suspensionHIV-1 infected infants and childrenApproved
AZN72.0382.6862.69Forxiga (dapagliflozin)Type 2 diabetes1/11/2014ApprovedApproved three days prior to PDUFA
BMY63.6869.2046.30Forxiga (dapagliflozin)Type 2 diabetes1/11/2014ApprovedApproved three days prior to PDUFA
SNY52.1457.4243.57LemtradaRelapsing forms of multiple sclerosis.CRLCRL 29/12/13
UTHR187.91190.2984.63Oral treprostinilPulmonary arterial hypertension (PAH)2/16/2014ApprovedApproved Dec 20 2013. Early approval following previous extension
THRX17.6731.8010.58UMEC/VI (62.5/25mcg and 125/25mcg doses) ANORO ELLIPTAChronic Obstructive Pulmonary Disease (COPD)12/18/2013ApprovedApproved Dec 18 2013
JNJ99.79109.4995.10Canagliflozin and immediate-release metforminAdults with type 2 diabetesCRL
GILD103.34116.8368.34Sovaldi (Sofosbuvir)HCV6/12/2013Approved
AUXL36.4737.9217.10XIAFLEXPeyronie’s6/12/2013ApprovedApproved Dec 6 2013
PCYC258.02260.4782.51Ibrutinib 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
ZGNX1.603.101.07Zohydro ERModerate to severe painApprovedApproved Oct 25 2013. Decision was delayed by several months
AGN240.22241.78115.94JUVÉDERM VOLUMA XCAge-related volume loss in the cheek area in adults over the age of 21ApprovedApproved Oct 23 2013
ALIOF124.28129.2593.00Macitentan (Opsumit)Pulmonary arterial hypertension10/18/2013ApprovedApproved Oct 18 2013
ALIM5.106.544.12IluvienDiabetic macular edema10/17/2013CRLCRL Nov 2011. Second CRL Oct 17 2013. Adcom meeting Jan 27 2014
PSDV4.064.943.31IluvienDiabetic macular edema10/17/2013CRLCRL Nov 2011. Second CRL Oct 17 2013. Adcom meeting Jan 27 2014
ATRS2.973.201.82OTREXUPRheumatoid arthritis (RA)10/14/2013ApprovedApproved Oct 14 2013
DCTH1.064.100.91CHEMOSAT systemCancer - unresectable metastatic ocular melanoma in the liver9/13/2013CRL CRL Sept 13 2013
CELG116.36129.0668.38ABRAXANEMetastatic pancreatic cancer9/21/2013ApprovedApproved Sep 6 2013
QRXPY0.053.410.04MOXDUOModerate to severe acute pain8/26/2013CRLCRL Aug 2013. Expects to resubmit 4Q 2013. Expects Adcom meeting
SUPN13.4913.687.09Trokendi XR SPN-538EpilepsyApprovedApproved Aug 19 2013
JNJ99.79109.4995.10SIMPONI ARIARheumatoid ArthritisApprovedApproved Jul 18 2013
MRK57.8463.6252.49Suvorexant tabletsInsomniaCRLAdcom May 22 2013. 13-3 positive vote. CRL received Jul 1 2013
GSK47.5856.4841.25Dolutegravir - ViiV HealthcareHIV8/17/2013ApprovedPDUFA Aug 12 under priority review.
JNJ99.79109.4995.10XARELTO (rivaroxaban)Stent Thrombosis in Patients with Acute Coronary SyndromeCRLCRL issued Jun 28 2013
THRX17.6731.8010.58VIBATIV (telavancin hydrochloride) for injectionHospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP)ApprovedApproved Jun 21 2013
AMGN166.87173.14108.20XGEVACancer - Giant Cell Tumor Of BoneApprovedApproved 6/13/13
AVEO1.722.020.61TivozanibCancer - advanced renal cell carcinoma7/28/2013CRLNegative 1-13 vote at Adcom meeting May 2 2013.Early CRL Jun 10 2013
CELG116.36129.0668.38REVLIMIDCancer - relapsed/refractory mantle cell lymphomaApproved Approved Jun 5 2013 under priority review
FLML16.2619.509.30Bloxiverz (neostigmine methylsulfate)Reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery5/31/2013ApprovedApproved Jun 3 2013
DEPO27.0627.249.85SEFELSAHot flashes5/31/2013CRLCRL May 31 2013
ENDP95.1196.5855.41AVEED (testosterone undecanoate) intramuscular injectionMen diagnosed with hypogonadismCRLCRL issued May 30 2013. Expects to respond 3Q 2013
GSK47.5856.4841.25DabrafenibCancer - melanoma6/3/2013Approved Approved May 29 2013
GSK47.5856.4841.25TrametinibCancer - melanoma6/3/2013ApprovedApproved May 29 2013
VRX207.36211.57106.00EfinaconazoleOnychomycosis5/24/2013CRLCRL May 28 2013
JNJ99.79109.4995.10SIMPONI (golimumab) ulcerative colitis (UC)ApprovedApproved May 16
THRX17.6731.8010.58BREO ELLIPTAChronic Obstructive Pulmonary Disease (COPD)5/12/2013ApprovedApproved May 10 2013
GSK47.5856.4841.25BREO ELLIPTAChronic Obstructive Pulmonary Disease (COPD)5/12/2013ApprovedApproved May 10 2013
BMY63.6869.2046.30SUSTIVA® (efavirenz)HIV-1ApprovedsNDA approved May 3 2013
MRK57.8463.6252.49LIPTRUZET (ezetimibe and atorvastatin)LDL CholesterolApprovedApproved May 3 2013
SHPG244.15264.98145.34Vyvanse® (lisdexamfetamine dimesylate) Children and Adolescents with ADHD5/1/2013ApprovedApproved May 1 2013
TTNP0.700.870.44ProbuphineOpioid dependence4/30/2013CRLCRL issued midnight Apr 30
RPTP11.0012.207.12DR CysteamineCystinosis4/30/2013ApprovedApproved Apr 30, 2013.
GILD103.34116.8368.34ElvitegravirHIV4/27/2013CRLCRL Apr 29 2013
GILD103.34116.8368.34CobicistatHIV4/28/2013CRLCRL Apr 29 2013
SCMP20.2420.535.80Amitiza/ LubiprostoneOpioid-induced bowel dysfunction4/24/2013ApprovedApproved Apr 23 2013
NVS103.31103.8083.71Simbrinza(TM) SuspensionGlaucomaApprovedApproved Apr 19 2013
JNJ99.79109.4995.10InvokanaType 2 diabetes3/31/2013ApprovedApproved Mar 29 2013
APPA14.23APF530Prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV)3/27/2013CRLCRL Mar 28 2013. Changed ticker to HRTX
UTHR187.91190.2984.63Treprostinil diolamine extended release tablets (oral treprostinil)Pulmonary arterial hypertension3/31/2013CRLCRL Mar 25, 6 days early
NAVB1.552.020.97LymphoseekLymphatic-tissue tracing agent4/30/2013Approved Approved Mar 13 2013. 7 weeks early.
JNJ99.79109.4995.10XARELTOReduction 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.
DVAX24.1626.8912.50HEPLISAVHepatitis B2/24/2013CRLCRL Feb 25 2013. Hopes to meet with FDA by mid April to discuss CRL
IMGN10.0814.805.34KadcylaCancer - 2nd-line HER2+ Metastatic Breast Cancer2/26/2013ApprovedApproved Feb 22 2013 - under priority review
NVS103.31103.8083.71Zortress (everolimus)Prevent organ rejection in adult liver transplant patientsApprovedApproved Feb 15 2013
CELG116.36129.0668.38PomalystCancer - Multiple Myeloma2/10/2013ApprovedApproved Feb 8 2013
HEB0.230.400.21Ampligen CFS2/4/2013CRLCRL Feb 4 2012. Resubmission. More trials required. Intends to appeal
HPTX45.9046.9620.23RavictiUrea cycle disorders1/22/2013ApprovedApproved Feb 1 2013. FDA had advised company of delay
FURX0.00#N/A#N/AAlogliptinDiabetes - Type 21/27/2013Approved NDA resubmitted July 27 2012, following CRL. Approved Jan 25 2013
IPXL51.2652.1022.12IPX066Parkinson'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.
AEGR26.0547.1319.10LomitapideHomozygous familial hypercholesterolemia (HoFH)1/6/2013ApprovedEarly approval Dec 24 2012
ALXA1.975.271.25Staccato loxapine (ADASUVE). Schizophrenia12/21/2012Approved
NPSP0.00#N/A#N/AGattexShort bowel syndrome or SBS12/30/2012ApprovedPDUFA date was Dec 30 2012. Early approval on Dec 21
ARIA9.109.194.90Oral ponatinibCancer - chronic myeloid leukemia, acute lymphoblastic leukemia3/27/2013ApprovedPDUFA March 27 2013. Early approval Dec 14 2012 under priority review
EXEL3.104.551.26CabozantinibCancer - Medullary thyroid 11/29/2012ApprovedApproved Nov 29 2012 under priority review
LGND86.8587.1741.99Promacta/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
SUPN13.4913.687.09OxtellarEpilepsy10/22/2012Approved
NAVB1.552.020.97LymphoseekLymphatic-tissue tracing agent9/10/2012CRL3rd party manufacturing deficiencies cited
MDVN130.79141.5855.25MDV3100Cancer - 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
HALO15.5216.556.88HyQPrimary immunodeficiency diseaseCRL
PGNX6.527.843.10Subcutaneous RELISTORchronic pain7/27/2012CRLPrice shown is for PGNX. Partnered with SLXP
AMRN2.373.330.78Vascepa Elevated triglyceride levels7/26/2012Approved
HZNP30.9730.997.85LODOTRA (RAYOS)Rheumetoid Arthritis7/26/2012Approved
ONXXCarfilzomibMultiple myeloma7/20/2012ApprovedAcquired by Amgen.
VVUS2.425.952.28QnexaObesity7/18/2012Approved
ARNA4.667.223.26LorcaserinObesity6/27/2012Approved
QRX0.020.750.01MOXDUOModerate to severe acute pain6/26/2012CRL
RGEN32.3034.1514.75RG1068Detection of pancreatic duct abnormalities6/22/2012CRL
XNPT7.399.603.14HorizantPostherpetic Neuralgia6/9/2012Approved
ARIA9.109.194.90RidaforolimusSoft tissue or bone sarcoma6/6/2012CRL
EBS30.1630.9619.31BioThraxAnthrax Vaccine5/17/2012ApprovedApproved May 17 2012
TLON0.161.830.13MarqiboPhiladelphia chromosome-negative acute lymphoblastic leukemia 5/13/2012Extended
ALXA1.975.271.25ADASUVESchizophrenia5/3/2012CRL
PLX2.014.401.53Taliglucerase alfa Gaucher disease5/1/2012Approved
VVUS2.425.952.28AvanafilErectile dysfunction4/29/2012Approved
PGNX6.527.843.10Subcutaneous RELISTORChronic pain4/27/2012ExtendedPrice shown is for PGNX
FURX0.00#N/A#N/AAlogliptinDiabetes - Type 24/25/2012CRL
VVUS2.425.952.28QnexaObesity4/17/2012Extended
CHTPNORTHERA Neurogenic Orthostatic Hypotension3/28/2012CRLAcquired by Lundbeck
AFFY0.110.740.08PeginesatideAnemia in chronic renal failure (CRF)3/27/2012ApprovedBankrupt
MAPPLevadexMigraine3/26/2012CRLAcquired by Allergan
CRIS2.773.501.09VismodegibBasal Cell Carcinoma3/8/2012ApprovedEarly decision Jan 30,2012
NGSX0.010.010.00QutenzaNeuropathic pain associated with HIV-associated peripheral neuropathy (HIV-PN)3/7/2012CRL
DSCO1.382.030.99Surfaxin Respiratory Distress Syndrome - Severe3/6/2012Approved
ASTXDacogenAcute myeloid leukemia3/6/2012CRLAcquired by Otsuka
CBRX#N/A#N/A#N/AProgesterone vaginal gelReduction of risk of preterm birth2/26/2012CRL
CORT6.036.651.69Corlux - KorlymCushing's Syndrome2/17/2012Approved
BPAXBio-T-GelMale hypogonadism2/14/2012ApprovedMerged. New ticker ANIP
ALXA1.975.271.25ADASUVESchizophrenia2/4/2012Extended 3months
AMLNBYDUREONType 2 diabetes1/28/2012ApprovedAcquired by Bristol-Myers Squibb
ALKS63.6875.1738.49BYDUREONType 2 diabetes1/28/2012Approved
PLX2.014.401.53Taliglucerase alfa Gaucher disease1/2/2012Extended 3 monthsInformed Dec 6 2011
NEOLSUBSYSCancer pain1/1/2012ApprovedNew ticker INSY
AIS2.97142.70128.00AnturolOveractive bladder12/8/2011ApprovedChanged ticker to ATRS
INCY102.76103.7442.74JakafiMyelofibrosis12/3/2011ApprovedApproved Nov 16 2011
TSPT#N/A#N/A#N/AIntermezzoInsomnia11/27/2011Approved
SPPI6.099.275.58Removal of the Bioscan Requirement for ZevalinNon-Hodgkin's lymphoma11/20/2011Approved
ALIM5.10ILUVIENDiabetic macular edema11/12/2011CRLEarly CRL. Price shown is for ALIM
IGXT0.680.950.33CPI-300Major Depressive Disorder11/10/2011Approved
PCRX83.47121.9563.56EXPARELPostsurgical pain10/28/2011Approved
SGEN36.5744.9530.05ADCETRISHodgkin lymphoma8/30/2011Approved
SGEN36.5744.9530.05ADCETRISAnaplastic large cell lymphoma8/30/2011Approved
PATHZelrixMigraine8/29/2011CRLAcquired by TEVA.
MSTX0.480.730.40ExelbineNSCLC8/9/2011CRLNew ticker MSTX. Formerly ANX
TSPT#N/A#N/A#N/AIntermezzoInsomnia7/14/2011CRL
PTIE1.896.221.61REMOXYModerate to severe pain6/23/2011CRL
FCSC4.035.992.28LavivWrinkles6/22/2011Approved
ACUR0.801.450.41OxectaPain relief6/17/2011Approved
OPTRFidaxomicinCDI - diarrhea5/30/2011Approved
SPPI6.099.275.58FUSILEVColorectal cancer4/29/2011Approved
XNPT7.399.603.14HorizantRestless Legs Syndrome4/6/2011Approved
HGSI0.00BENLYSTALupus3/10/2011Approved
PLX2.014.401.53Taliglucerase alfa Gaucher disease2/25/2011CRL
OREX7.809.373.11ContraveObesity1/31/2011CRL
DEPO27.0627.249.85GRALISEPostherpetic neuralgia - shingles1/30/2011Approved
MNKD5.1811.484.45AfrezzaInsulin1/26/2011CRLEarly 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
BIOD1.132.560.99VIAjectDiabetes10/30/2010CRL
AVNR16.9617.053.02NUEDEXTAPseudobulbar affect10/30/2010Approved
VVUS2.425.952.28QnexaObesity10/28/2010CRL
ALKS/AMLN#N/ABYDUREONType 2 diabetes10/22/2010CRL
ISTA0.00BROMDAYPostoperative inflammation and reduction of ocular pain10/16/2010ApprovedAcquired by Bausch + Lomb
QCOR0.00#N/A#N/AActharInfantile spasms10/15/2010Approved
ALXA1.975.271.25ADASUVESchizophrenia10/11/2010CRL
JAZZ189.92190.48120.38JZP-6Fibromyalgia10/11/2010CRL
HGSIZALBINHepatitis C10/5/2010CRLAcquired by GSK
PGNX6.527.843.10RelistorOpioid-induced constipation (OIC)9/29/2010Approved
SVNTKRYSTEXXAGout9/14/2010ApprovedBankrupt
QCOR0.00#N/A#N/AActharInfantile spasms6/11/2010Extended 4 months
POZN8.069.735.96VIMOVOGastric ulcers4/30/2010Approved
ITMN0.00#N/A#N/AEsbrietIdiopathic pulmonary fibrosis 4/5/2010CRL
SLXP172.81172.9886.00XIFAXANHepatic encephalopathy3/24/2010Approved
CTIC1.913.361.77PixuvriNon-Hodgkin's lymphoma3/23/2010CRL
SOMX3.005.441.29SilenorInsomnia3/19/2010Approved
APPA14.23APF530Chemotherapy-induced nausea and vomiting3/18/2010CRLChanged ticker to HRTX
SUPG0.00DacogenMyelodysplastic syndromes3/8/2010ApprovedChanged ticker to ASTX
ALKS63.68BYDUREONType 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
XNPT7.399.603.14HorizantRestless Legs Syndrome2/9/2010CRL
PLX2.014.401.53Taliglucerase alfa Gaucher disease2/9/2010Extended
ACOR34.6845.4528.26AMPYRAImprove walking in patients with multiple sclerosis1/22/2010Approved
MNKD5.1811.484.45AFREZZADiabetes1/16/2010CRLFDA responded 15 Mar 2010
FCSC4.035.992.28LavivWrinkles1/4/2010CRLEarly CRL
VIONOnriginAcute myeloid leukemia12/12/2009CRLBankrupt
SOMX3.005.441.29SilenorInsomnia12/4/2009CRL
SNTSZEGERIDGERD12/4/2009ApprovedAcquired by Salix.
DYAX28.4330.556.05KALBITORHereditary angioedema 12/1/2009Approved
NGSX0.010.00QutenzaPostherpetic neuralgia11/16/2009Approved
CADXOFIRMEVMild to moderate pain11/13/2009Approved
TSPT#N/A#N/A#N/AIntermezzoInsomnia11/2/2009CRL
GTXI0.741.700.41ToremifeneReduce fractures in men with prostate cancer10/30/2009CRL
SPPI6.099.275.58FUSILEVColorectal cancer10/8/2009CRL
ALTH#N/A#N/AFOLOTYNPeripheral T-cell lymphoma9/24/2009Approved
ISTABepreveAllergic conjunctivitis9/14/2009ApprovedAcquired by Bausch + Lomb
SPPI6.099.275.58ZEVALINNon-Hodgkin's Lymphoma 9/7/2009Approved
NGSX0.010.010.00QutenzaPostherpetic neuralgia8/17/2009Extended 3 months
SVNTKRYSTEXXAGout8/3/2009CRLBankrupt
DDSS#N/AOleptroMajor depressive disorder7/20/2009CRLBankrupt
ZGNX1.603.101.07SumavelMigraine7/15/2009Approved
ARDM6.67SumavelMigraine7/15/2009Approved
SPPI6.099.275.58ZEVALINNHL7/2/2009CRL
HEB0.230.400.21AmpligenChronic 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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