New Drug Applications
The New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States.
The purpose of a NDA is to provide enough information to permit the FDA to reach the following key decisions
- Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks
- Whether the drug's proposed labeling (package insert) is appropriate and what it should contain
- Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity
For more information on New Drug Applications, please visit the FDA's How Drugs are Developed and Approved page.
Kovaltry (factor VIII (recombinant))
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Hemophilia A
Kovaltry (factor VIII (recombinant)) is an investigational plasma protein-free compound in development for the treatment of hemophilia A.
Company: Actelion Ltd.
Treatment for: Pulmonary Hypertension
Uptravi (selexipag) is a potent, orally available, selective IP prostacyclin receptor agonist in development for the treatment of pulmonary arterial hypertension.
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Reversal Agent for Pradaxa
Idarucizumab is a humanized antibody fragment, or Fab, being investigated as a specific reversal agent for the anticoagulant effect of dabigatran (Pradaxa).
Company: Shire plc
Treatment for: Dry Eye Disease
Lifitegrast is a topical integrin antagonist in development for the treatment of dry eye disease.
Company: Newron Pharmaceuticals S.p.A.
Treatment for: Parkinson's Disease
Xadago (safinamide) is an alpha-aminoamide in development as an add-on therapy to dopamine agonists or to levodopa in patients with early or mid- to late-stage Parkinson’s disease.
- Xadago (safinamide) NDA Accepted for Filing by the U.S. FDA - March 2, 2015
- Safinamide NDA Re-submitted to the U.S. FDA - December 29, 2014
Company: Mapp Biopharmaceutical, Inc.
Treatment for: Ebola Virus Disease
ZMapp is a combination of three chimeric monoclonal antibodies manufactured in the Nicotiana benthamiana tobacco plant that has been used in the experimental treatment of Ebola virus disease.
Company: Otonomy, Inc.
Treatment for: Otitis Media
AuriPro (ciprofloxacin) is a sustained-exposure otic fluoroquinolone formulation in development for the treatment of middle ear effusion in pediatric patients undergoing tympanostomy tube placement (TTP) surgery.
- Otonomy Submits New Drug Application to the FDA for AuriPro - February 26, 2015
Belbuca (buprenorphine hydrochloride) Buccal Film
Company: Endo Pharmaceuticals Inc.
Treatment for: Chronic Pain
Belbuca (buprenorphine) is an opioid analgesic buccal film formulation in development for the management of chronic pain.
TAS-102 (tipiracil hydrochloride and trifluridine)
Company: Taiho Oncology, Inc.
Treatment for: Colorectal Cancer
TAS-102 (trifluridine and tipiracil hydrochloride) is an antineoplastic nucleoside analog and thymidine phosphorylase inhibitor combination in development for the treatment of refractory metastatic colorectal cancer (mCRC).
Treatment for: Melanoma - Metastatic
Cobimetinib is an investigational MEK inhibitor in development for the combination treatment of advanced melanoma.
Company: Oncolytics Biotech Inc.
Treatment for: Ovarian Cancer, Pancreatic Cancer
Reolysin (pelareorep) is a proprietary formulation of the human reovirus (Respiratory Enteric Orphan Virus) in development for the treatment of various cancers and cell proliferative disorders.
Company: Sprout Pharmaceuticals, Inc.
Treatment for: Hypoactive Sexual Desire Disorder
Flibanserin is a novel, non-hormonal, multifunctional serotonin agonist antagonist (MSAA) in development for the treatment of hypoactive sexual desire disorder in premenopausal women.
- Sprout Pharmaceuticals Resubmits Flibanserin NDA for Hypoactive Sexual Desire Disorder In Premenopausal Women - February 17, 2015
- Sprout Pharmaceuticals Receives Clear Guidance from FDA on Path Forward to Resubmit NDA for Flibanserin - February 11, 2014
- Sprout Pharmaceuticals Appeals FDA Decision on NDA for Flibanserin to Treat Hypoactive Sexual Desire Disorder in Premenopausal Women - December 11, 2013
ALO-02 (naltrexone and oxycodone) Extended-Release Capsules
Company: Pfizer Inc.
Treatment for: Pain
ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride) is an extended-release, abuse-deterrent, narcotic analgesic formulation for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.
Xtampza ER (oxycodone) Extended-Release Capsules
Company: Collegium Pharmaceutical, Inc.
Treatment for: Chronic Pain
Xtampza ER (oxycodone) is an extended-release, abuse-deterrent narcotic analgesic in development for the treatment of chronic pain.
Lenvima (lenvatinib) Capsules
Company: Eisai Co., Ltd.
Treatment for: Thyroid Cancer
Lenvima (lenvatinib) is an oral multiple receptor tyrosine kinase (RTK) inhibitor for the treatment of progressive radioiodine-refractory differentiated thyroid cancer.
- FDA Approves Lenvima (lenvatinib) for Differentiated Thyroid Cancer - February 13, 2015
- Lenvatinib Phase III Trial Results Published in New England Journal of Medicine - February 12, 2015
- Phase II Trial of Anticancer Agent Lenvatinib in Renal Cell Carcinoma Meets Primary Endpoint - January 30, 2015
- U.S. FDA Grants Priority Review Status to NDA for Anticancer Agent Lenvatinib - October 15, 2014
MorphaBond ER (morphine sulfate) Extended-Release Tablets
Company: Inspirion Delivery Technologies, LLC
Treatment for: Pain
MorphaBond ER (morphine sulfate extended-release) is an abuse-deterrent, opioid analgesic formulation in development for the treatment of pain severe enough to require daily, around-the-clock, long-term opioid treatment.
Company: Hemispherx Biopharma, Inc.
Treatment for: Chronic Fatigue Syndrome
Ampligen (rintatolimod) is an experimental nucleic acid therapeutic in development for the treatment of a variety of chronic diseases and viral disorders.
- Hemispherx Biopharma Posts USAMRIID Ebola Study Concluding Ampligen Produced 100% Survival Rate in Rodents with 100% Mortality in Placebo - February 9, 2015
- Hemispherx Announces Data Showing Inhibition of Ebola by Ampligen Enlarged by Howard University Research - December 9, 2014
- Hemispherx Biopharma Receives Complete Response Letter From FDA on Ampligen New Drug Application for Chronic Fatigue Syndrome - February 5, 2013
- FDA Advisory Committee Makes Recommendations on Ampligen for Chronic Fatigue Syndrome - December 27, 2012
- Hemispherx Biopharma Announces FDA Confirms Advisory Committee Meeting on December 20, 2012 - October 23, 2012
- Hemispherx Biopharma Announces FDA Advisory Committee Will Review Ampligen for Chronic Fatigue Syndrome - September 24, 2012
- FDA Accepts Complete Response Submission Regarding the Ampligen New Drug Application for Chronic Fatigue Syndrome - August 14, 2012
- Hemispherx Biopharma Files Complete Response With the FDA Regarding Its Ampligen New Drug Application for Chronic Fatigue Syndrome - August 1, 2012
- Hemispherx Biopharma Reaches Agreement With FDA on Specific Steps to Achieve Complete NDA on Proposed CFS Treatment Ampligen - March 7, 2008
- Hemispherx Biopharma Addresses FDA Questions On Ampligen NDA - January 9, 2008
- Hemispherx Biopharma Files New Drug Application for Ampligen as Treatment for Chronic Fatigue Syndrome - October 11, 2007
Company: Ortho Biotech Products, L.P.
Treatment for: Ovarian Cancer, Soft Tissue Sarcoma
Yondelis (trabectedin) is an investigational cytotoxic antitumor agent in development for the treatment of relapsed ovarian cancer, and advanced soft tissue sarcoma.
- U.S. FDA Grants Priority Review for Yondelis (trabectedin) for the Treatment of Patients with Advanced Soft Tissue Sarcoma - February 3, 2015
- Janssen Submits NDA for Yondelis (trabectedin) for Advanced Soft Tissue Sarcoma - November 24, 2014
- Centocor Ortho Biotech Products, L.P. Voluntarily Withdraws NDA for Trabectedin - April 29, 2011
- FDA Issues Complete Response Letter For Trabectedin Combined With Doxil - September 10, 2009
- Ortho Biotech Announces NDA Submission for Trabectedin for the Treatment of Relapsed Ovarian Cancer - November 20, 2008
Company: Repros Therapeutics Inc.
Treatment for: Hypogonadism -- Male
Androxal (enclomiphene) is a non-steroidal estrogen receptor antagonist in development for secondary hypogonadism in overweight men wishing to restore normal testicular function.
- Repros Submits New Drug Application to FDA for Androxal - February 2, 2015
- Repros Reports Both Primary Endpoints Successfully Met in First Pivotal Study of Androxal - March 27, 2013
- Repros Submits Response to FDA Regarding Androxal Indication for Treatment of Hypogonadal Men Wishing to Preserve Fertility - February 8, 2010