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.
Tlando (testosterone) - formerly LPCN 1021
Company: Lipocine Inc.
Treatment for: Hypogonadism -- Male
Tlando (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.
- Lipocine Announces FDA Acknowledgement of Tlando (LPCN 1021) NDA Resubmission - August 14, 2017
- Lipocine Resubmits NDA for Its Oral Testosterone Product Candidate, LPCN 1021, for Treatment of Hypogonadism - August 9, 2017
- Lipocine Receives Complete Response Letter (CRL) for LPCN 1021 From U.S. FDA - June 29, 2016
- Lipocine Announces PDUFA Goal Date for LPCN 1021 NDA - November 12, 2015
- FDA Accepts for Filing Lipocine's NDA for Its Oral Testosterone Replacement Product Candidate, LPCN 1021 - October 29, 2015
- Lipocine Submits NDA to FDA for Its Oral Testosterone Replacement Product Candidate, LPCN 1021 - August 31, 2015
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection
Bictegravir, emtricitabine and tenofovir alafenamide is an investigational integrase strand transfer inhibitor and emtricitabine/tenofovir alafenamide (FTC/TAF) combination in development for the treatment of HIV-1 infection in adults.
- Gilead Announces U.S. FDA Priority Review Designation for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV - August 10, 2017
- Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for HIV Treatment - June 12, 2017
Vesneo (latanoprostene bunod) Ophthalmic Solution
Company: Valeant Pharmaceuticals International, Inc.
Treatment for: Glaucoma (Open Angle), Intraocular Hypertension
Vesneo (latanoprostene bunod ophthalmic solution) is a nitric oxide donating prostaglandin receptor agonist in development for the treatment of patients with open angle glaucoma or ocular hypertension.
- Valeant Pharmaceuticals Receives Complete Response Letter from the FDA for Latanoprostene Bunod Ophthalmic Solution, 0.024% NDA - August 7, 2017
- Bausch + Lomb And Nicox Announce PDUFA Date For Novel Glaucoma Candidate Latanoprostene Bunod - March 20, 2017
- Bausch + Lomb And Nicox Resubmit US New Drug Application For Novel Glaucoma Candidate Latanoprostene Bunod - February 27, 2017
- Valeant Pharmaceuticals Receives FDA Complete Response Letter for Latanoprostene Bunod - July 22, 2016
- Bausch+Lomb and Nicox Announce FDA Acceptance of NDA for Novel Glaucoma Candidate Vesneo (latanoprostene bunod) - September 22, 2015
Heplisav-B (hepatitis b adult vaccine)
Company: Dynavax Technologies Corporation
Treatment for: Hepatitis B Prophylaxis
Heplisav-B (hepatitis b adult vaccine) is an investigational vaccine intended for use in the immunization against infection caused by all known subtypes of hepatitis B virus.
- Dynavax Provides U.S. Regulatory Update on Heplisav-B Following FDA Advisory Committee Meeting - August 3, 2017
- Dynavax Announces FDA Advisory Committee Vote in Favor of Heplisav-B - July 28, 2017
- Dynavax Receives Complete Response Letter from U.S. FDA for Biologics License Application for Heplisav-B - November 14, 2016
- Dynavax Provides Regulatory Update on Heplisav-B - October 4, 2016
- Dynavax Reports Feedback From FDA Meeting Regarding Heplisav Biologic License Application - June 10, 2013
- Dynavax Receives FDA Complete Response Letter on Heplisav Biologic License Application - February 25, 2013
- Dynavax Announces FDA Advisory Committee Meeting Outcome for Heplisav - November 16, 2012
- Dynavax Announces FDA Advisory Committee to Review Heplisav - August 29, 2012
- Dynavax Announces FDA Acceptance of Heplisav BLA - June 27, 2012
- Dynavax Reports Heplisav BLA Submission - April 27, 2012
Company: Janssen Biotech, Inc.
Treatment for: Rheumatoid Arthritis
Plivensia (sirukumab) is a human anti-interleukin-6 monoclonal antibody in development for the treatment of rheumatoid arthritis.
Treatment for: Mantle Cell Lymphoma
Acalabrutinib is an investigational, highly selective, potent, Bruton tyrosine kinase (BTK) inhibitor in development for the treatment of mantle cell lymphoma (MCL).
Linhaliq (ciprofloxacin liposomal) for Inhalation
Company: Aradigm Corporation
Linhaliq is an inhalation formulation of liposome encapsulated and unencapsulated ciprofloxacin in development for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infections with Pseudomonas aeruginosa.
Twirla (ethinyl estradiol and levonorgestrel) Transdermal System
Company: Agile Therapeutics, Inc.
Treatment for: Contraception
Twirla (ethinyl estradiol and levonorgestrel transdermal system) is an investigational low-dose combined hormonal contraceptive.
Company: Eli Lilly and Company and Incyte Corporation
Treatment for: Rheumatoid Arthritis
Baricitinib is an oral selective JAK1 and JAK2 inhibitor in development for the treatment of rheumatoid arthritis.
- Lilly and Incyte Provide Update on Baricitinib - July 25, 2017
- FDA Issues Complete Response Letter for Baricitinib - April 14, 2017
- U.S. FDA Extends Review Period For Baricitinib, An Investigational Rheumatoid Arthritis Treatment - January 13, 2017
- Lilly and Incyte Announce Submission of NDA to FDA for Oral Once-Daily Baricitinib for Treatment of Moderate-to-Severe Rheumatoid Arthritis - January 19, 2016
Lusduna Nexvue (insulin glargine) - formerly MK-1293
Company: Merck & Co., Inc.
Treatment for: Diabetes Type 1, Diabetes Type 2
Lusduna Nexvue (insulin glargine injection) is a follow-on biologic (biosimilar) to Lantus in development for the treatment of patients with type 1 and type 2 diabetes.
- Merck Announces U.S. FDA Grants Tentative Approval for Lusduna Nexvue (insulin glargine injection), a Follow-On Biologic Basal Insulin - July 20, 2017
- Merck Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for MK-1293, an Investigational Follow-On Biologic Insulin Glargine - August 5, 2016
Yonsa (abiraterone acetate)
Company: Churchill Pharmaceuticals, LLC
Treatment for: Prostate Cancer
Yonsa (abiraterone acetate) is an improved ultramicrosize formulation of the oral CYP17 inhibitor abiraterone acetate (approved as Zytiga) in development for the combination treatment of metastatic castration-resistant prostate cancer.
Company: Camurus and Braeburn Pharmaceuticals
Treatment for: Opiate Dependence
CAM2038 (buprenorphine) is a long-acting partial opioid agonist formulation in development for the treatment of opioid dependence.
Company: Amgen Inc.
Treatment for: Migraine Prophylaxis
Aimovig (erenumab) is a human monoclonal antibody that inhibits the receptor for calcitonin gene-related peptide (CGRP) in development for the prevention of episodic and chronic migraine.
Macrilen (macimorelin acetate)
Company: Aeterna Zentaris Inc.
Treatment for: Adult Human Growth Hormone Deficiency
Macrilen (macimorelin) is a ghrelin agonist in development for use in evaluating adult growth hormone deficiency (AGHD).
- NDA for Macrilen for the Evaluation of Growth Hormone Deficiency in Adults Granted December 30, 2017 PDUFA Date - July 18, 2017
- Aeterna Zentaris Resubmits NDA for Macrilen for the Evaluation of Growth Hormone Deficiency in Adults - June 30, 2017
- Aeterna Zentaris Intends to File NDA with Respect to Macrilen in Third Quarter of 2017 - March 30, 2017
- Aeterna Zentaris Announces Plans to Pursue FDA Registration of Macrilen - February 13, 2017
- Aeterna Zentaris Completes Patient Recruitment for Confirmatory Phase 3 Trial of Macrilen - October 26, 2016
- Aeterna Zentaris Announces Plans to Initiate Phase 3 Study of Macrilen in AGHD - April 13, 2015
- FDA Issues Complete Response Letter for Macrilen (macimorelin) NDA in Adult Growth Hormone Deficiency - November 6, 2014
- Aeterna Zentaris NDA for Macimorelin Acetate in AGHD Accepted for Filing by the FDA - January 6, 2014
- Aeterna Zentaris Submits New Drug Application to FDA for Macimorelin Acetate (AEZS-130) for Evaluation of AGHD - November 5, 2013
Company: Amgen Inc.
Treatment for: Osteoporosis
Evenity (romosozumab) is an anti-sclerostin monoclonal antibody in development for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.
- Amgen and UCB Receive Complete Response Letter from U.S. FDA for Evenity (romosozumab) BLA - July 16, 2017
- Amgen And UCB Announce U.S. FDA Acceptance Of Biologics License Application For Romosozumab - September 26, 2016
- Amgen and UCB Submit Biologics License Application for Romosozumab to the FDA - July 21, 2016
Company: Novartis Pharmaceuticals Corporation
Treatment for: Acute Lymphoblastic Leukemia
CTL019 (tisagenlecleucel-T) is an investigational chimeric antigen receptor T cell (CAR-T) therapy in development for use in relapsed and refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL).
- Novartis CAR-T Cell Therapy CTL019 Unanimously (10-0) Recommended for Approval by FDA Advisory Committee to Treat Pediatric, Young Adult r/r B-Cell ALL - July 12, 2017
- Novartis CAR-T Cell Therapy CTL019 Receives FDA Breakthrough Therapy Designation for Treatment of Adult Patients with r/r DLBCL - April 18, 2017
- Novartis Announces First CAR-T Cell Therapy BLA for Pediatric and Young Adult Patients with r/r B-Cell ALL Granted FDA Priority Review - March 29, 2017
Company: Eli Lilly and Company
Treatment for: Breast Cancer
Abemaciclib is a selective ATP-competitive inhibitor of cyclin dependent kinases (CDK) 4 and 6 in development for the treatment of metastatic breast cancer.
Company: Amicus Therapeutics
Treatment for: Fabry Disease
Migalastat (AT1001) is an investigational pharmacological chaperone in development for the treatment of Fabry disease.
- FDA Confirms Amicus Therapeutics May Submit New Drug Application for Migalastat for Fabry Disease - July 11, 2017
- Amicus Therapeutics Announces U.S. Regulatory Pathway for Migalastat for Fabry Disease - November 28, 2016
- Amicus Therapeutics Plans to Submit NDA for Migalastat for Fabry Disease Following Positive Pre-NDA Meeting With FDA - September 15, 2015