FDA Historical Calendar

TickerCurrent price52 hi52 loProductIndicationPDUFA dateDecisionNotes
FLML11.8826.097.56AkovazHypotension4/30/2016ApprovedAnnounced approval May 2 2016
ACAD27.5351.9916.64PimavanserinParkinson’s disease psychosis (PDP)5/1/2016ApprovedApproved April 29 2016
EXEL4.336.802.80CABOMETYX (cabozantinib)Cancer - metastatic renal cell cancer (RCC)6/22/2016ApprovedApproved April 25 2016. PDUFA date under priority review was June 22 2016
CHMA2.5030.522.95MycapssaAcromegaly4/15/2016CRLCRL April 15 2016
OPK9.8019.207.12RAYALDEESecondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) and vitamin D insufficiency3/29/2016CRLCRL issued March 29 2016 - citing third-party manufacturing issues
EGRX37.58104.1733.02KANGIO (bivalirudin injection)Percutaneous Coronary Intervention (PCI) and Percutaneous Transluminal Coronary Angioplasty (PTCA)3/19/2016CRLCRL issued March 18 2016. FDA requested further characterization of bivalirudin-related substances in the drug product
SPPI6.967.744.14EVOMELA (melphalan) for InjectionConditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma5/9/2016ApprovedApproved March 15, 2016. Original PDUFA was May 9 2016
LGND120.39131.8471.63EVOMELA (melphalan) for InjectionConditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma5/9/2016ApprovedApproved March 15, 2016. Original PDUFA was May 9 2016
VRTX80.63143.4575.90ALYDECO (ivacaftor)Cystic fibrosis (CF) ages 2 and older who have one of 23 residual function mutations.2/7/2016CRLCRL issued February 5, 2016
BNHLF0.070.750.04MCNABladder cancer2/27/2016CRL
NEOS8.8228.997.57Adzenys XR-ODTAttention deficit hyperactivity disorder (ADHD)1/27/2016ApprovedApproved January 27 2016
BMRN82.14151.7562.12KyndrisaDuchenne Muscular Dystrophy (DMD)12/27/2015CRLCRL issued January 14 2016
VRTX80.63143.4575.90Lumacaftor and ivacaftorCystic fibrosis (CF) ages 12 and older who have two copies of the F508del mutation ApprovedApproved July 2 2015
SPPI6.967.744.14Captisol-Enabled MelphalanConditioning treatment prior to autologous stem cell transplant for patients with multiple myelomaCRLCRL October 23 2015
SGEN33.1052.3326.02ADCETRIS - AETHERACancer - post-transplant Hodgkin lymphoma (HL) patientsApprovedApproved August 18, 2015 under priority review
RPRX2.218.960.80EnclomipheneSecondary hypogonadismCRLCRL December 1 2015.
RLYP14.0037.4510.26Patiromer for Oral Suspension (Patiromer FOS)HyperkalemiaApprovedApproved October 21 2015
OTIC13.0233.2812.17OTIPRIO (ciprofloxacin otic suspension) Ear Tube Placement SurgeryApprovedApproved December 11 2015
OPK9.8019.207.12Rolapitant Prevention of chemotherapy induced nausea and vomiting, or CINV ApprovedApproved September 2 2015
TSRO40.0666.9529.51Rolapitant Prevention of chemotherapy induced nausea and vomiting, or CINV ApprovedApproved September 2 2016
NKTR14.0217.559.16ADYNOVATEHemophilia A ApprovedApproved November 16 2015
MACK6.3913.265.02ONIVYDECancer - second line pancreaticApprovedApproved October 22 2015 under priority review
EXEL4.336.802.80VemurafenibCancer - BRAF V600 Mutation-Positive Advanced MelanomaApprovedApproved November 10
EGRX37.58104.1733.02Docetaxel InjectionBreast, non-small cell lung, prostate gastric adenocarcinoma, and head and neck cancerApprovedApproved December 24 2015
ALIOF160.50162.39122.00Selexipag - UptraviPulmonary arterial hypertension (PAH)ApprovedApproved Dec 22 2015
ALKS37.6280.7127.14AristadaSchizophreniaApprovedApproved October 5 2015
ALXN141.41208.88124.16Asfotase alfaHypophosphatasia (HPP)ApprovedApproved December 8 2015
BDSI2.909.912.53BEMA BuprenorphineManagement of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequateApprovedApproved October 26 2015
ENDP2.9088.8425.23BEMA BuprenorphineManagement of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequateApprovedApproved October 26 2015
EBS37.9540.9627.68BioThrax Anthrax Vaccine AdsorbedApprovedApproved November 24 2015
PTX1.067.100.73TREXIMETAdolescent migraine patients5/14/2015Approved Approved May 15 2015
THRX#N/A#N/A#N/ABREO ELLIPTAAsthma4/30/2015Approved Approved April 30 2015
MDCO34.2443.7925.27RAPLIXAHemostasis4/30/2015ApprovedApproved April 30 2015
MDCO34.2443.7925.27IONSYSAcute postoperative painApproved5/2/2015
KYTH0.00#N/A#N/AATX-101 Reduction of Localized Subcutaneous Fat in the Submental Area5/13/2015ApprovedApproved April 29 2015
LLY74.8992.8567.88CYRAMZASecond-Line Treatment of Metastatic Colorectal CancerApprovedApproved April 24 2015
MNTA9.4825.567.86Generic CopaxoneMultiple sclerosisApprovedFiled 2007. Approved mid April 16 2015
AMGN154.18181.81130.09CorlanorChronic Heart Failure5/27/2015ApprovedApproved April 15 2015
EBS37.9540.9627.68Anthrax Immune Globulin Intravenous (Human) [AIGIV] AnthraxApprovedApproved March 25 2015
VRTX80.63143.4575.90Vacaftor 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
BMY70.7673.0651.82OpdivoAdvanced Squamous Non-Small Cell Lung Cancer6/22/2015ApprovedApproved March 4 2015
PCRX48.8381.2835.78EXPARELSingle-dose injection femoral nerve block for total knee arthroplasty surgery3/5/2015CRLPDUFA CRL March 2 2015.
SNY40.3754.9837.63ToujeoType 1 and type 2 diabetesApprovedApproved Feb 26 2015
ESALY52.1571.8655.81Lenvatinib mesylate (lenvatinib)Differentiated thyroid cancer (DTC) 4/14/2015ApprovedApproved Feb 13 2015
PCYC0.00#N/A#N/AIMBRUVICAWaldenström’s Macroglobulinemia4/17/2015ApprovedApproved Jan 29, 2015
ZGNX9.9121.657.90 Abuse deterrent formulations of Zohydro ERModerate to severe pain1/30/2015ApprovedApproved January 30 2015
RMTI7.6418.905.47Soluble Ferric PyrophosphateIron deficiency1/24/2015ApprovedApproved Jan 26 2015
NPSPNatparaHypoparathyroidism1/24/2015ApprovedApproved Jan 23 2015
IPXL32.2751.4229.66IPX066Parkinson's Approved Jan 8 2015
VRTX80.63143.4575.90KALYDECOCystic fibrosis (CF) ages 6 and older who have the R117H mutation12/30/2014ApprovedApproved Dec 28 2014
ADMS15.7331.8412.02NamzaricModerate to severe dementia of the Alzheimer's type.ApprovedApproved Dec 24 2014
BCRX3.0016.831.63Peramivir INFLUENZA ACUTE 12/23/2014ApprovedApproved Dec 22 2014
ENTA25.0651.8916.75VIEKIRA PAKHCV - genotype 112/21/2014ApprovedApproved December 19 2014
ABBV61.4671.6045.45VIEKIRA 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
POZN5.9412.695.49PA32540 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
INCY68.69133.6255.00Jakafi Polycythemia Vera5/12/2014ApprovedApproved December 4 2014
AVNR16.9617.053.02AVP-825Acute migraine11/26/2014CRLCRL November 26 2014 - likely to resubmit 1H 2015
AEZS3.4757.992.60Macimorelin AcetateAdult Growth Deficiency 11/5/2014CRL New trials required
PGNX5.1911.153.61Subcutaneous RELISTORChronic pain9/29/2014Approved
SLXP172.81172.9886.00Subcutaneous RELISTORChronic pain9/29/2014Approved
ALIM2.215.151.49IluvienDiabetic macular edema9/26/2014Approved Sept 26 2014
PSDV2.855.812.37IluvienDiabetic 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.
VVUS1.372.650.92AvanafilErectile dysfunction9/20/2014ApprovedApproved 9/18/2014 - sNDA to change label allowing use 15 minutes before sexual activity.
NKTR14.0217.559.16NaloxegolOpioid-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
HALO9.9025.256.96HYQVIASubcutaneous treatment for patients with primary immunodeficiency (PI)ApprovedApproved Sept 12 2014
OREX0.446.960.39ContraveObesity9/11/2014ApprovedApproved September 11 2014
MDVN59.0666.3926.41XTANDICancer - mCRPC who have not received chemotherapy9/17/2014ApprovedApproved Sept 10 2014
KERX5.2111.122.80ZerenexHyperphosphatemia9/7/2014ApprovedApproved Sept 5 2014
LGND120.39131.8471.63PromactaAplastic AnemiaApproved Approved August 27 2014
MDCO34.2443.7925.27OritavancinABSSSI8/6/2014ApprovedApproved under priority review
PCYC0.00#N/A#N/AIbrutinib Deletion 17pApprovedApproved July 29 2014
PCYC0.00#N/A#N/AIbrutinib Cancer - Refractory Chronic Lymphocytic Leukemia/Small Cell Lymphocytic Lymphoma (CLL/SLL)ApprovedApproved July 29 2014
ACRX3.135.882.59ZalvisoPost-operative pain following open abdominal surgery and hip or knee replacement surgery7/27/2014CRLCRL Jul 26 2014
EGRX37.58104.1733.02RyanodexMalignant hyperthermia7/22/2014Approved
SLXP172.81172.9886.00RUCONESTHereditary angioedema (HAE)7/16/2014Approved Partnered with Dutch company Pharming
ANAC61.33156.9352.00TavaboroleOnychomycosis7/29/2014ApprovedApproved July 8 2014
SPPI6.967.744.14BelinostatCancer - Peripheral T-Cell Lymphoma8/9/2014ApprovedApproved two months early under accelerated approval program.
EGRX37.58104.1733.02EP-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
FLML11.8826.097.56VAZCULEP (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
MNKD1.417.320.64AFREZZA 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
NAVB1.322.490.75LymphoseekHead and Neck Cancer6/16/2014ApprovedApproved Jun 13 2014
BDSI2.909.912.53BEMA Buprenorphine/Naloxone (BNX) - BUNAVAILOpioid dependence6/7/2014ApprovedApproved June 7 2014
OMER12.2830.238.90OmidriaCataract surgery6/1/2014Approved Approved June 2 2014
TRLPF0.140.580.06Loading...PDUFA5/28/2014PDUFA date February 28 2014, extended to May 28 2014, for bioadhesive intranasal gel testosterone product (CompleoTRT)
QRXPY0.000.170.00MOXDUOModerate 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
FLML11.8826.097.56??????4/28/2014CRLCRL April 28 2014
MDCO34.2443.7925.27CangrelorReduction of thrombotic cardiovascular events including stent thrombosis in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI).4/30/2014CRLCRL April 30 2014
POZN5.9412.695.49PA32540 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
BMY70.7673.0651.82Eliquis To Reduce The Risk Of Blood Clots Following Hip Or Knee Replacement Surgery3/15/2014ApprovedApproved March 14 2014
PFE33.4236.4628.25EliquisTo Reduce The Risk Of Blood Clots Following Hip Or Knee Replacement Surgery3/15/2014ApprovedApproved March 14 2014
ENDP27.3788.8425.23AVEED (testosterone undecanoate) intramuscular injectionMen diagnosed with hypogonadism3/28/2014ApprovedApproved March 6 2014
AZN28.2735.3327.68MetreleptinLipodystrophy2/27/2014ApprovedApproved Feb 25 2014
BMY70.7673.0651.82MetreleptinLipodystrophy2/27/2014ApprovedApproved Feb 25 2014
CHTPNORTHERA Neurogenic Orthostatic HypotensionApprovedApprovedApproved one day late due to snow. Acquired by Lundbeck
BMRN82.14151.7562.12Vimizim (GALNS)(MPS IVA) Morquio A Syndrome2/28/2014Approved Early approval. Was under priority review
DRRX1.423.420.99PosidurPost-operative pain relief 2/12/2014CRL
PCYC0.00#N/A#N/AIbrutinib Cancer - Chronic Lymphocytic Leukemia Who Have Received at Least One Prior Therapy2/28/2014ApprovedApproved Feb 12 2014
VNDA8.3214.506.91HETLIOZ (tasimelteon)Non-24-Hour Sleep-Wake Disorder1/31/2014Approved
VRX34.77263.8125.27Retin-A Micro (tretinoin) Gel microsphere 0.08% Acne vulgarisApprovedsNDA
AMAG19.5577.7319.35FerahemeIron 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
AZN28.2735.3327.68FARXIGA (dapagliflozin) tablets Adult patients with type 2 diabetesApproved
BMY70.7673.0651.82FARXIGA (dapagliflozin) tabletsAdult patients with type 2 diabetesApproved
GSK42.3646.7637.24Mekinist (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
MRK54.8061.7045.69ISENTRESS for oral suspensionHIV-1 infected infants and childrenApproved
AZN28.2735.3327.68Forxiga (dapagliflozin)Type 2 diabetes1/11/2014ApprovedApproved three days prior to PDUFA
BMY70.7673.0651.82Forxiga (dapagliflozin)Type 2 diabetes1/11/2014ApprovedApproved three days prior to PDUFA
SNY40.3754.9837.63LemtradaRelapsing forms of multiple sclerosis.CRLCRL 29/12/13
UTHR108.20190.13102.50Oral treprostinilPulmonary arterial hypertension (PAH)2/16/2014ApprovedApproved Dec 20 2013. Early approval following previous extension
THRX#N/A#N/A#N/AUMEC/VI (62.5/25mcg and 125/25mcg doses) ANORO ELLIPTAChronic Obstructive Pulmonary Disease (COPD)12/18/2013ApprovedApproved Dec 18 2013
JNJ112.22114.1981.79Canagliflozin and immediate-release metforminAdults with type 2 diabetesCRL
GILD85.60123.3781.89Sovaldi (Sofosbuvir)HCV6/12/2013Approved
AUXL36.4737.9217.10XIAFLEXPeyronie’s6/12/2013ApprovedApproved Dec 6 2013
PCYC0.00#N/A#N/AIbrutinib 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
ZGNX9.9121.657.90Zohydro ERModerate to severe painApprovedApproved Oct 25 2013. Decision was delayed by several months
AGN214.70340.34211.35JUVÉDERM VOLUMA XCAge-related volume loss in the cheek area in adults over the age of 21ApprovedApproved Oct 23 2013
ALIOF160.50162.39122.00Macitentan (Opsumit)Pulmonary arterial hypertension10/18/2013ApprovedApproved Oct 18 2013
ALIM2.215.151.49IluvienDiabetic macular edema10/17/2013CRLCRL Nov 2011. Second CRL Oct 17 2013. Adcom meeting Jan 27 2014
PSDV2.855.812.37IluvienDiabetic macular edema10/17/2013CRLCRL Nov 2011. Second CRL Oct 17 2013. Adcom meeting Jan 27 2014
ATRS0.972.600.67OTREXUPRheumatoid arthritis (RA)10/14/2013ApprovedApproved Oct 14 2013
DCTH0.301.920.25CHEMOSAT systemCancer - unresectable metastatic ocular melanoma in the liver9/13/2013CRL CRL Sept 13 2013
CELG100.90140.7292.98ABRAXANEMetastatic pancreatic cancer9/21/2013ApprovedApproved Sep 6 2013
QRXPY0.000.170.00MOXDUOModerate to severe acute pain8/26/2013CRLCRL Aug 2013. Expects to resubmit 4Q 2013. Expects Adcom meeting
SUPN15.9023.309.51Trokendi XR SPN-538EpilepsyApprovedApproved Aug 19 2013
JNJ112.22114.1981.79SIMPONI ARIARheumatoid ArthritisApprovedApproved Jul 18 2013
MRK54.8061.7045.69Suvorexant tabletsInsomniaCRLAdcom May 22 2013. 13-3 positive vote. CRL received Jul 1 2013
GSK42.3646.7637.24Dolutegravir - ViiV HealthcareHIV8/17/2013ApprovedPDUFA Aug 12 under priority review.
JNJ112.22114.1981.79XARELTO (rivaroxaban)Stent Thrombosis in Patients with Acute Coronary SyndromeCRLCRL issued Jun 28 2013
THRX#N/A#N/A#N/AVIBATIV (telavancin hydrochloride) for injectionHospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP)ApprovedApproved Jun 21 2013
AMGN154.18181.81130.09XGEVACancer - Giant Cell Tumor Of BoneApprovedApproved 6/13/13
AVEO0.893.500.82TivozanibCancer - advanced renal cell carcinoma7/28/2013CRLNegative 1-13 vote at Adcom meeting May 2 2013.Early CRL Jun 10 2013
CELG100.90140.7292.98REVLIMIDCancer - relapsed/refractory mantle cell lymphomaApproved Approved Jun 5 2013 under priority review
FLML11.8826.097.56Bloxiverz (neostigmine methylsulfate)Reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery5/31/2013ApprovedApproved Jun 3 2013
DEPO16.5433.7412.25SEFELSAHot flashes5/31/2013CRLCRL May 31 2013
ENDP27.3788.8425.23AVEED (testosterone undecanoate) intramuscular injectionMen diagnosed with hypogonadismCRLCRL issued May 30 2013. Expects to respond 3Q 2013
GSK42.3646.7637.24DabrafenibCancer - melanoma6/3/2013Approved Approved May 29 2013
GSK42.3646.7637.24TrametinibCancer - melanoma6/3/2013ApprovedApproved May 29 2013
VRX34.77263.8125.27EfinaconazoleOnychomycosis5/24/2013CRLCRL May 28 2013
JNJ112.22114.1981.79SIMPONI (golimumab) ulcerative colitis (UC)ApprovedApproved May 16
THRX#N/A#N/A#N/ABREO ELLIPTAChronic Obstructive Pulmonary Disease (COPD)5/12/2013ApprovedApproved May 10 2013
GSK42.3646.7637.24BREO ELLIPTAChronic Obstructive Pulmonary Disease (COPD)5/12/2013ApprovedApproved May 10 2013
BMY70.7673.0651.82SUSTIVA® (efavirenz)HIV-1ApprovedsNDA approved May 3 2013
MRK54.8061.7045.69LIPTRUZET (ezetimibe and atorvastatin)LDL CholesterolApprovedApproved May 3 2013
SHPG178.46270.63147.60Vyvanse® (lisdexamfetamine dimesylate) Children and Adolescents with ADHD5/1/2013ApprovedApproved May 1 2013
TTNP6.1110.002.57ProbuphineOpioid dependence4/30/2013CRLCRL issued midnight Apr 30
RPTP4.6816.282.94DR CysteamineCystinosis4/30/2013ApprovedApproved Apr 30, 2013.
GILD85.60123.3781.89ElvitegravirHIV4/27/2013CRLCRL Apr 29 2013
GILD85.60123.3781.89CobicistatHIV4/28/2013CRLCRL Apr 29 2013
SCMP10.7429.679.59Amitiza/ LubiprostoneOpioid-induced bowel dysfunction4/24/2013ApprovedApproved Apr 23 2013
NVS74.33106.8469.89Simbrinza(TM) SuspensionGlaucomaApprovedApproved Apr 19 2013
JNJ112.22114.1981.79InvokanaType 2 diabetes3/31/2013ApprovedApproved Mar 29 2013
APPA19.80APF530Prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV)3/27/2013CRLCRL Mar 28 2013. Changed ticker to HRTX
UTHR108.20190.13102.50Treprostinil diolamine extended release tablets (oral treprostinil)Pulmonary arterial hypertension3/31/2013CRLCRL Mar 25, 6 days early
NAVB1.322.490.75LymphoseekLymphatic-tissue tracing agent4/30/2013Approved Approved Mar 13 2013. 7 weeks early.
JNJ112.22114.1981.79XARELTOReduction 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.
DVAX14.9432.4914.68HEPLISAVHepatitis B2/24/2013CRLCRL Feb 25 2013. Hopes to meet with FDA by mid April to discuss CRL
IMGN6.1719.435.94KadcylaCancer - 2nd-line HER2+ Metastatic Breast Cancer2/26/2013ApprovedApproved Feb 22 2013 - under priority review
NVS74.33106.8469.89Zortress (everolimus)Prevent organ rejection in adult liver transplant patientsApprovedApproved Feb 15 2013
CELG100.90140.7292.98PomalystCancer - Multiple Myeloma2/10/2013ApprovedApproved Feb 8 2013
HEB0.130.290.06Ampligen CFS2/4/2013CRLCRL Feb 4 2012. Resubmission. More trials required. Intends to appeal
HPTX45.9946.9620.23RavictiUrea 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
IPXL32.2751.4229.66IPX066Parkinson'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.
AEGR2.3923.112.36LomitapideHomozygous familial hypercholesterolemia (HoFH)1/6/2013ApprovedEarly approval Dec 24 2012
ALXA0.581.990.22Staccato 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
ARIA6.6510.074.37Oral ponatinibCancer - chronic myeloid leukemia, acute lymphoblastic leukemia3/27/2013ApprovedPDUFA March 27 2013. Early approval Dec 14 2012 under priority review
EXEL4.336.802.80CabozantinibCancer - Medullary thyroid 11/29/2012ApprovedApproved Nov 29 2012 under priority review
LGND120.39131.8471.63Promacta/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
SUPN15.9023.309.51OxtellarEpilepsy10/22/2012Approved
NAVB1.322.490.75LymphoseekLymphatic-tissue tracing agent9/10/2012CRL3rd party manufacturing deficiencies cited
MDVN59.0666.3926.41MDV3100Cancer - 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
HALO9.9025.256.96HyQPrimary immunodeficiency diseaseCRL
PGNX5.1911.153.61Subcutaneous RELISTORchronic pain7/27/2012CRLPrice shown is for PGNX. Partnered with SLXP
AMRN1.802.801.24Vascepa Elevated triglyceride levels7/26/2012Approved
HZNP14.7339.4912.86LODOTRA (RAYOS)Rheumetoid Arthritis7/26/2012Approved
ONXXCarfilzomibMultiple myeloma7/20/2012ApprovedAcquired by Amgen.
VVUS1.372.650.92QnexaObesity7/18/2012Approved
ARNA1.585.121.30LorcaserinObesity6/27/2012Approved
QRX0.030.070.00MOXDUOModerate to severe acute pain6/26/2012CRL
RGEN25.7142.4820.07RG1068Detection of pancreatic duct abnormalities6/22/2012CRL
XNPT4.217.863.35HorizantPostherpetic Neuralgia6/9/2012Approved
ARIA6.6510.074.37RidaforolimusSoft tissue or bone sarcoma6/6/2012CRL
EBS37.9540.9627.68BioThraxAnthrax Vaccine5/17/2012ApprovedApproved May 17 2012
TLON0.161.830.13MarqiboPhiladelphia chromosome-negative acute lymphoblastic leukemia 5/13/2012Extended
ALXA0.581.990.22ADASUVESchizophrenia5/3/2012CRL
PLX0.832.350.74Taliglucerase alfa Gaucher disease5/1/2012Approved
VVUS1.372.650.92AvanafilErectile dysfunction4/29/2012Approved
PGNX5.1911.153.61Subcutaneous RELISTORChronic pain4/27/2012ExtendedPrice shown is for PGNX
FURX0.00#N/A#N/AAlogliptinDiabetes - Type 24/25/2012CRL
VVUS1.372.650.92QnexaObesity4/17/2012Extended
CHTPNORTHERA Neurogenic Orthostatic Hypotension3/28/2012CRLAcquired by Lundbeck
AFFY0.090.120.07PeginesatideAnemia in chronic renal failure (CRF)3/27/2012ApprovedBankrupt
MAPPLevadexMigraine3/26/2012CRLAcquired by Allergan
CRIS1.853.751.25VismodegibBasal Cell Carcinoma3/8/2012ApprovedEarly decision Jan 30,2012
NGSX0.000.010.00QutenzaNeuropathic pain associated with HIV-associated peripheral neuropathy (HIV-PN)3/7/2012CRL
DSCO#N/A#N/A#N/ASurfaxin 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
CORT4.757.673.22Corlux - KorlymCushing's Syndrome2/17/2012Approved
BPAXBio-T-GelMale hypogonadism2/14/2012ApprovedMerged. New ticker ANIP
ALXA0.581.990.22ADASUVESchizophrenia2/4/2012Extended 3months
AMLNBYDUREONType 2 diabetes1/28/2012ApprovedAcquired by Bristol-Myers Squibb
ALKS37.6280.7127.14BYDUREONType 2 diabetes1/28/2012Approved
PLX0.832.350.74Taliglucerase alfa Gaucher disease1/2/2012Extended 3 monthsInformed Dec 6 2011
NEOLSUBSYSCancer pain1/1/2012ApprovedNew ticker INSY
AIS0.97142.70128.00AnturolOveractive bladder12/8/2011ApprovedChanged ticker to ATRS
INCY68.69133.6255.00JakafiMyelofibrosis12/3/2011ApprovedApproved Nov 16 2011
TSPT#N/A#N/A#N/AIntermezzoInsomnia11/27/2011Approved
SPPI6.967.744.14Removal of the Bioscan Requirement for ZevalinNon-Hodgkin's lymphoma11/20/2011Approved
ALIM2.21ILUVIENDiabetic macular edema11/12/2011CRLEarly CRL. Price shown is for ALIM
IGXT0.570.690.37CPI-300Major Depressive Disorder11/10/2011Approved
PCRX48.8381.2835.78EXPARELPostsurgical pain10/28/2011Approved
SGEN33.1052.3326.02ADCETRISHodgkin lymphoma8/30/2011Approved
SGEN33.1052.3326.02ADCETRISAnaplastic large cell lymphoma8/30/2011Approved
PATHZelrixMigraine8/29/2011CRLAcquired by TEVA.
MSTX0.330.600.21ExelbineNSCLC8/9/2011CRLNew ticker MSTX. Formerly ANX
TSPT#N/A#N/A#N/AIntermezzoInsomnia7/14/2011CRL
PTIE2.323.651.53REMOXYModerate to severe pain6/23/2011CRL
FCSC2.387.602.04LavivWrinkles6/22/2011Approved
ACUR2.696.751.61OxectaPain relief6/17/2011Approved
OPTRFidaxomicinCDI - diarrhea5/30/2011Approved
SPPI6.967.744.14FUSILEVColorectal cancer4/29/2011Approved
XNPT4.217.863.35HorizantRestless Legs Syndrome4/6/2011Approved
HGSI0.00BENLYSTALupus3/10/2011Approved
PLX0.832.350.74Taliglucerase alfa Gaucher disease2/25/2011CRL
OREX0.446.960.39ContraveObesity1/31/2011CRL
DEPO16.5433.7412.25GRALISEPostherpetic neuralgia - shingles1/30/2011Approved
MNKD1.417.320.64AfrezzaInsulin1/26/2011CRLEarly 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
BIOD0.371.230.22VIAjectDiabetes10/30/2010CRL
AVNR16.9617.053.02NUEDEXTAPseudobulbar affect10/30/2010Approved
VVUS1.372.650.92QnexaObesity10/28/2010CRL
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
ALXA0.581.990.22ADASUVESchizophrenia10/11/2010CRL
JAZZ148.58194.73108.50JZP-6Fibromyalgia10/11/2010CRL
HGSIZALBINHepatitis C10/5/2010CRLAcquired by GSK
PGNX5.1911.153.61RelistorOpioid-induced constipation (OIC)9/29/2010Approved
SVNTKRYSTEXXAGout9/14/2010ApprovedBankrupt
QCOR0.00#N/A#N/AActharInfantile spasms6/11/2010Extended 4 months
POZN5.9412.695.49VIMOVOGastric ulcers4/30/2010Approved
ITMN0.00#N/A#N/AEsbrietIdiopathic pulmonary fibrosis 4/5/2010CRL
SLXP172.81172.9886.00XIFAXANHepatic encephalopathy3/24/2010Approved
CTIC0.442.460.25PixuvriNon-Hodgkin's lymphoma3/23/2010CRL
SOMX3.005.441.29SilenorInsomnia3/19/2010Approved
APPA19.80APF530Chemotherapy-induced nausea and vomiting3/18/2010CRLChanged ticker to HRTX
SUPG0.00DacogenMyelodysplastic syndromes3/8/2010ApprovedChanged ticker to ASTX
ALKS37.62BYDUREONType 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
XNPT4.217.863.35HorizantRestless Legs Syndrome2/9/2010CRL
PLX0.832.350.74Taliglucerase alfa Gaucher disease2/9/2010Extended
ACOR25.4643.6324.83AMPYRAImprove walking in patients with multiple sclerosis1/22/2010Approved
MNKD1.417.320.64AFREZZADiabetes1/16/2010CRLFDA responded 15 Mar 2010
FCSC2.387.602.04LavivWrinkles1/4/2010CRLEarly CRL
VIONOnriginAcute myeloid leukemia12/12/2009CRLBankrupt
SOMX3.005.441.29SilenorInsomnia12/4/2009CRL
SNTSZEGERIDGERD12/4/2009ApprovedAcquired by Salix.
DYAX0.00#N/A#N/AKALBITORHereditary 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
GTXI0.721.590.29ToremifeneReduce fractures in men with prostate cancer10/30/2009CRL
SPPI6.967.744.14FUSILEVColorectal cancer10/8/2009CRL
ALTH#N/A#N/AFOLOTYNPeripheral T-cell lymphoma9/24/2009Approved
ISTABepreveAllergic conjunctivitis9/14/2009ApprovedAcquired by Bausch + Lomb
SPPI6.967.744.14ZEVALINNon-Hodgkin's Lymphoma 9/7/2009Approved
NGSX0.000.010.00QutenzaPostherpetic neuralgia8/17/2009Extended 3 months
SVNTKRYSTEXXAGout8/3/2009CRLBankrupt
DDSS#N/AOleptroMajor depressive disorder7/20/2009CRLBankrupt
ZGNX9.9121.657.90SumavelMigraine7/15/2009Approved
ARDM4.45SumavelMigraine7/15/2009Approved
SPPI6.967.744.14ZEVALINNHL7/2/2009CRL
HEB0.130.290.06AmpligenChronic 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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