List of FDA dates
STOCK PICS AWAITING FDA APPROVAL
This post features companies with expected FDA approval decision dates for the year. Further insight can be found using the key codes which designate each drug candidate's likelihood of approval and potential competition.
KEY DEFINITIONS
PDUFA (Prescription Drug User Fee Act)
NDA (New Drug Application)
RED DATES - Dates confirmed directly w/company (this research provided by paid resource publication) or indirectly through company filings and press releases.
UNDERLINED DATES - Estimated dates based on NDA submissions
PMOA - Primary Mode of Action; The means by which a product achieves its intended therapeutic effect or action
Y - Yes
N - No
Proven PMOA? - Y designates yes, the drug has proven PMOA; N designates PMOA not yet proved.
Two or Fewer Alternatives? - <2 designates upon approval drug is likely to compete with two or fewer alternative sources in same drug class. <2! designates drug is the sole candidate with this PMOA. Additional information provided refers to potential competitors; 3+ designates there are many competitors for this drug.
1-2 Previously Approved? - Y designates at least 1-2 drugs were previously approved by FDA for this company; N designates no drugs were previously approved. If criteria is left empty, information was not available.
NOTES
Drug candidates are sometimes filed jointly by two companies.
CREDITS
Data is comprised from paid resource report (compliments of colorwonder) and BioMedReports and/or anything else I can get my hands on!
Spinner: FDA FUNDS
Garyd: FDA CALENDAR
JUNE 2009
Currently under $10/per share
HEB- 5/25 - DATE EXTENDED UFN (%$#@@!)
Ampligen (Poly I: Poly C12U) experimental treatment for chronic fatigue syndrome (which has no FDA-approved treatments) and the drug has an Orphan Drug. BioMedReports
VPHM 6/3
Cinryze (Human C1 Inhibitor): Treatment of acute attacks of hereditary angioedema.
BDSI 6/12 (mid-June)
Onsolis (Fentanyl Buccal Soluble Film)/Formerly BEMA Fentanyl: Breakthrough cancer pain in opioid tolerant patients. BioMedReports
6/2/09 UPDATE: Since the FDA has informed BDSI that all other aspects of the NDA review are complete, the prospects for Onsolis approval are excellent, with an approval decision possible by mid-June based on a Class II (six-month) review by the agency on the re-submission. SeekingAlpha
ISTA FDA REVIEW 6/26/09:
Bepreve (bepotastine ophthalmic solution)
On 6/1/09, ISTA announced the Dermatologic and Ophthalmic Drugs Advisory Committee will review ISTA's NDA for Bepreve on June 26, 2009. SeekingAlpha
ACUR 6/30
Remoxy (Time-Release Oxycodone) PTIE Y
Acurox (Abuse Resistant Oxycodone/Niacin )/Formerly OxyADF: Abuse resistant relief of moderate to severe pain
KG 6/30
Acurox (Oxycodone/Niacin Abuse Resistant)/Formerly OxyADF: Abuse resistant relief of moderate to severe pain.
JULY 2009
Currently under $10/per share
SPPI 7/2
Zevalin (Ibritumomab Tiuxetan): First-line consolidation therapy in for previously untreated follicular indolent Non-Hodgkin's Lymphoma. BioMedReports
TSPT REVISED DATE (cancel 7/3 - refer 10/31/09)
Zolpimist (Zolpidem Tartrate Oral Spray)NVD; Ambien (Zolpidem Tartrate)SNY Y
Intermezzo (zolpidem sublingual lozenge) NDA for use as-needed to treat insomnia from middle of the night awakenings.
UPDATE (thumbs up for Ingew): Transcept Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has informed the company that it should expect to receive formal notice of a three month extension of the review period for the new drug application (NDA) for Intermezzo(R) (zolpidem tartrate sublingual tablet). The Intermezzo(R) NDA had been assigned a Prescription Drug User Fee Act (PDUFA) date of July 30, 2009. Under this revised timeline, Transcept now anticipates action from the FDA on the NDA on or before October 31, 2009. PR NEWS WIRE 6/11/09
ARDM 7/15 (refer spinner)
Sumavel (of privately-held company Zogenix). Zogenix have bought Aradigm's non-injection delivery system and ARDM stand to reap potential licensing rewards from this drug if approved.
DDSS 7/18
Y 3+ Y
Trazodone (DDS-04A) for the treatment of depression through the 505(b)(2) regulatory pathway for new formulations drugs that are already on the market. BioMedReport
MEDX 7/30
Y <2 Genzyme Oncology CAMPATH (Alemtuzumab) GENZ Y
Arzerra (Ofatumumab): B-Cell Chronic Lymphocytic Leukemia
SVNT 7/30
Y <2! Y
Krystexxa (Pegloticase): Elimination of excess uric acid (Hyperuricemia) in individuals with symptomatic gout that is unresponsive to conventional treatment.
ADLS.OB (ADLS Google) 6/2 7/31
Y <2 Ketek (Telithromycin) [STOCK]SNY[/STOCK] N
Restanza (cethromycin) as a once-daily antibiotic for the treatment of adults with mild to moderate community acquired pneumonia. 5/19 OTC Investor
ADLS UPDATE 6/2/09: Anti-Infective Drugs Advisory Committee of the FDA is scheduled to meet on 6/2/09 to discuss the NDA for cethromycin and provide a recommendation for the final FDA approval decision. Briefing documents for the panel meeting can be accessed here.
ADLS UPDATE 6/2/09 AH - AP Newswire: FDA's Anti-Infective Drugs Advisory Committee voted in the majority that Restanza (cethromycin) demonstrated safety for the outpatient treatment of adults with mild-to-moderate community acquired pneumonia (CAP). However, the committee voted that Restanza did not demonstrate efficacy in the treatment of CAP. ...Although it is not binding, the Committee's recommendation will be considered by the FDA as it completes its review of Restanza's NDA in CAP.
ADLS UPDATE: 6/23/09 BioMedReported good news after the company announced that a second non-human primate study showed that a 14-day course of Restanza achieved a 100% survival rate against an inhaled lethal dose of anthrax.
AUGUST 2009
Currently under $10/per share
NRIFF.PK 8/5 (NRIFF.PK Google)
Pennsaid, 8/5 expected decision date of PDUFA for company's NDA re-submission for topical NSAID for arthritis pain and inflammation. BioMedReport
NGSX 8/16
Qutenza (formerly NGX-4010) for treatment of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain. BioMedReport
UPDATE 5/21/09: NGSX announced that the European Commission has formally granted marketing authorization of Qutenza 179 mg cutaneous patch for the prescription-only treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain. The centralized marketing authorization allows Qutenza to be marketed in all 27 countries of the European Union. SeekingAlpha 6/2/09
UPDATE 6/2/09: The Office of Orphan Product Development of FDA granted orphan drug designation for Qutenza. PR NewWire
UPDATE 7/24/09: NGSX Announces Preliminary Results of FDA-Requested Qutenza Study - NeurogesX, Inc. announced today the preliminary results of a short-term clinical study (Study C123) of Qutenza(TM) in patients with postherpetic neuralgia (PHN) following pretreatment with an FDA-approved topical anesthetic. ...Preliminary results of Study C123 showed the mean duration of patch application was 60.2 minutes, versus a target duration of Qutenza patch application of 60 minutes. No patients removed the Qutenza patch prematurely (i.e.< 90% of the intended full application time).
The company expects to provide results from Study C123 to the FDA prior to the PDUFA date of August 16, 2009. The impact on the agency's timing, if any, for an ultimate decision on the NDA is not yet known.
SEPTEMBER 2009
Currently under $10/per share
ISTA 9/12/09:
<2!
Bepreve (bepotastine ophthalmic solution)
Last November, ISTA announced it had filed its NDA with the FDA for Bepreve as an eye drop treatment for ocular itching associated with allergic conjunctivitis. STA continues to expect a standard review of ten months and has been given a PDUFA decision date of 9/12/09. SeekingAlpha
OCTOBER 2009
Currently under $10/per share
SPPI 10/8/09
Fusilev (levoleucovorin) for Injection to expand use of the drug in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. SeekingAlpha
TSPT 10/31
Y <2 Zolpimist (Zolpidem Tartrate Oral Spray) NVD; Ambien (Zolpidem Tartrate) SNY Y
Intermezzo (zolpidem sublingual lozenge) NDA for use as-needed to treat insomnia from middle of the night awakenings.
PR NEWSWIRE UPDATE: Transcept Pharmaceuticals, Inc. (NASDAQ: TSPT) announced today that the U.S. Food and Drug Administration (FDA) has informed the company that it should expect to receive formal notice of a three month extension of the review period for the new drug application (NDA) for Intermezzo(R) (zolpidem tartrate sublingual tablet). The Intermezzo(R) NDA had been assigned a Prescription Drug User Fee Act (PDUFA) date of July 30, 2009. Under this revised timeline, Transcept now anticipates action from the FDA on the NDA on or before October 31, 2009.
DECEMBER 2009
Currently under $10/per share
SNTS FDA REVIEW 12/4/09 Google
(No name) New tablet formulation to add to its Zegerid family of branded prescription pharmaceutical products. SeekingAlpha 6/2/09
VION.OB 12/12
Info not yet available
Onrigin (laromustine) Injection (formerly known as Cloretazine or VNP40101M) NDA requesting approval as a single agent for remission induction treatment for patients age 60 and older with de novo poor-risk acute myeloid leukemia. BioMedReport
NDA submissions – PDUFA dates pending
Currently under $10/per share
ACUS.PK - N/A (ACUS Google chart)
Imagify (Perflubutane Polymer Microspheres) for Injectable Suspension as a cardiac imaging agent for the detection of coronary artery disease. BioMedReport 5/24/09 BioMedReport (Article states, "There is no definitive timeline for a FDA decision on the NDA until further notice from the Comapany...)
APPA - N/A
Product (APF530) to the FDA for the prevention of chemotherapy-induced nausea and vomiting. APF530 is a long-acting formulation of granisetron that utilizes the Company’s proprietary Biochronomer drug delivery system. BioMedReport
THTCF - N/A NDA filed 6/1/09
<2!
Tesamorelin, an analogue of the growth hormone releasing factor, proposed for the treatment of excess abdominal fat in HIV patients with lipodystrophy. Several factors including the antiretroviral drug regimen and the virus itself are thought to contribute to HIV-associated lipodystrophy, which is characterized by body composition changes, dyslipidemia and glucose intolerance. The changes in body composition include excess abdominal fat accumulation. There is currently no approved treatment available for the excess abdominal fat related to HIV-associated lipodystrophy, a condition that can stigmatize patients and discourage HIV treatment adherence. SeekingAlpha
Biopharm Stock Analysis
Originally Posted by w00tw00t
As some of you may know I have been busy in the past few weeks collecting data about past FDA approval dates. I have managed to create a list of 62 dates going back to December 2007 and I’m going to extend this list in the near future. I’m going to perform as small analysis even if the list is somewhat small. The results are temporary and will be adjusted in the near future.
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