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.

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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.

Uptravi (selexipag)

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.

Xadago (safinamide)

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.


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.

AuriPro (ciprofloxacin)

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.

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).


Company: Genentech
Treatment for: Melanoma - Metastatic

Cobimetinib is an investigational MEK inhibitor in development for the combination treatment of advanced melanoma.

Reolysin (pelareorep)

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.

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.

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.

Ampligen (rintatolimod)

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.

Yondelis (trabectedin)

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.

Androxal (enclomiphene)

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.

See also: Generic Approvals, New Drug Approvals, Recent Additions to, Alphabetical Listing of all New Drug Applications, FDA Approval Process

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