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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.


Company: Valeant Pharmaceuticals International, Inc.
Treatment for: Plaque Psoriasis

Brodalumab is a human anti-interleukin-17-receptor monoclonal antibody in development for the treatment of plaque psoriasis.

SequestOx (naltrexone and oxycodone hydrochloride)

Company: Elite Pharmaceuticals, Inc.
Treatment for: Pain

SequestOx (oxycodone hydrochloride and naltrexone) is an abuse-deterrent opioid formulation in development for the management of moderate to severe pain.


Company: Synergy Pharmaceuticals Inc.
Treatment for: Constipation -- Chronic, Irritable Bowel Syndrome

Plecanatide is a uroguanylin analog in late-stage clinical development for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C).

Yuvvexy (estradiol) - formerly TX-004HR

Treatment for: Dyspareunia

Yuvvexy (estradiol) is a topical estrogen in an applicator-free, vaginal, softgel capsule formulation for the treatment of dyspareunia (vaginal pain during sexual intercourse) due to menopause.

Solithera (solithromycin)

Company: Cempra, Inc.
Treatment for: Community Acquired Bacterial Pneumonia

Solithera (solithromycin) is a next-generation oral and intravenous fluoroketolide in clinical development for the treatment of moderate to moderately-severe community acquired bacterial pneumonia (CABP).


Company: Array BioPharma
Treatment for: NRAS-Mutant Melanoma

Binimetinib is a late-stage small molecule MEK inhibitor in development for the treatment of advanced NRAS-mutant melanoma.

LPCN 1021 (testosterone)

Company: Lipocine Inc.
Treatment for: Hypogonadism -- Male

LPCN 1021 (testosterone) is an oral testosterone replacement therapy in development for the treatment of males with conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism.

Ocrevus (ocrelizumab)

Company: Genentech, Inc.
Treatment for: Multiple Sclerosis

Ocrevus (ocrelizumab) is a humanized monoclonal antibody designed to target CD20-positive B-cells, which are implicated in the inflammatory and neurodegenerative processes of multiple sclerosis. Ocrevus is an investigational treatment for both relapsing (RMS) and primary progressive (PPMS) forms of multiple sclerosis.


Company: Advanced Accelerator Applications S.A.
Treatment for: Neuroendocrine Carcinoma

Lutathera (177Lu-DOTATATE) is a Lu-177-labeled somatostatin analogue peptide in development for the treatment of gastroenteropancreatic neuroendocrine tumors.

ozenoxacin Cream

Company: Medimetriks Pharmaceuticals, Inc.
Treatment for: Impetigo

Ozenoxacin cream is a topical non-fluorinated quinolone in development for the treatment of impetigo.


Company: Mitsubishi Tanabe Pharma
Treatment for: Amyotrophic Lateral Sclerosis

Edaravone is a free radical scavenger that relieves the effects of oxidative stress, a likely factor in the onset and progression of amyotrophic lateral sclerosis.

AC-170 (cetirizine)

Company: Nicox S.A.
Treatment for: Allergic Conjunctivitis

AC-170 (cetirizine) is a second generation antihistamine topical ophthalmic formulation in development for the treatment of ocular itching associated with allergic conjunctivitis.


Company: Ariad Pharmaceuticals, Inc.
Treatment for: Non-Small Cell Lung Cancer

Brigatinib is an investigational anaplastic lymphoma kinase (ALK) inhibitor in development for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) non-small cell cancer (NSCLC) whose disease is resistant to crizotinib.

CL-108 (acetaminophen, hydrocodone and promethazine)

Company: Charleston Laboratories, Inc. and Daiichi Sankyo, Inc.
Treatment for: Pain, Nausea/Vomiting

CL-108 is an analgesic and antihistamine fixed-dose combination in development for the relief of moderate to severe pain while preventing or reducing the associated opioid-induced nausea and vomiting (OINV).

Apadaz (acetaminophen and benzhydrocodone hydrochloride) - formerly KP201

Company: KemPharm, Inc.
Treatment for: Pain

Apadaz (acetaminophen and benzhydrocodone hydrochloride) is an investigational abuse-deterrent narcotic analgesic combination in development for the short-term management of acute pain.

Zinplava (bezlotoxumab)

Company: Merck
Treatment for: Clostridial Infection

Zinplava (bezlotoxumab) is a selective, fully-human, monoclonal antibody designed to neutralize Clostridium difficile toxin B and prevent C. difficile infection recurrence.

Troxyca ER (naltrexone and oxycodone) Extended-Release Capsules - formerly ALO-02

Company: Pfizer Inc.
Treatment for: Pain

Troxyca ER (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.

Vantrela ER (hydrocodone bitartrate) Extended-Release Tablets

Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Pain

Vantrela ER (hydrocodone bitartrate) is an abuse deterrent opioid formulation in development for the management of severe pain.


Company: Sarepta Therapeutics, Inc.
Treatment for: Duchenne Muscular Dystrophy

Eteplirsen is a morpholino antisense oligomer in development for the treatment of Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping.

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

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