New Drug Approvals
The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.
See also: Generic Approvals, Approval Process, New Indications and Dosage forms
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Nocdurna (desmopressin acetate) Sublingual Tablets
Company: Ferring Pharmaceuticals Inc.
Date of Approval: June 21, 2018
Treatment for: Nocturia
Nocdurna (desmopressin acetate) is a vasopressin analog indicated for the treatment of nocturia due to nocturnal polyuria in adults.
- Nocdurna (desmopressin acetate) Approved by FDA as First Sublingual Tablet to Treat Nocturia due to Nocturnal Polyuria - June 21, 2018
moxidectin Tablets
Company: Medicines Development for Global Health
Date of Approval: June 13, 2018
Treatment for: Onchocerciasis
Moxidectin is a macrocyclic lactone anthelmintic medicine indicated for the treatment of river blindness (onchocerciasis) in patients aged 12 years and older.
- FDA Approves Moxidectin for the Treatment of River Blindness - June 13, 2018
Fulphila (pegfilgrastim-jmdb) Injection
Company: Mylan N.V.
Date of Approval: June 4, 2018
Treatment for: Neutropenia Associated with Chemotherapy
Fulphila (pegfilgrastim-jmbd) is a leukocyte growth factor biosimilar to Neulasta (pegfilgrastim) indicated to reduce the duration of febrile neutropenia in patients treated with chemotherapy.
Fulphila FDA Approval HistoryOlumiant (baricitinib) Tablets
Company: Eli Lilly and Company
Date of Approval: May 31, 2018
Treatment for: Rheumatoid Arthritis
Olumiant (baricitinib) is a Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis.
- FDA Approves Olumiant (baricitinib) 2 mg Tablets for the Treatment of Adults with Moderately-to-Severely Active Rheumatoid Arthritis - June 1, 2018
- FDA Advisory Committee Recommends the Approval of Baricitinib 2mg, but not 4mg, for the Treatment of Moderately-to-Severely Active Rheumatoid Arthritis - April 23, 2018
- Lilly to File Baricitinib Resubmission to U.S. FDA Before End of January 2018 - August 30, 2017
- 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
Consensi (amlodipine and celecoxib) Tablets - formerly KIT-302
Company: Kitov Pharma Ltd.
Date of Approval: May 31, 2018
Treatment for: Hypertension, Osteoarthritis
Consensi (amlodipine and celecoxib) is a calcium channel blocker and nonsteroidal anti-inflammatory drug combination for the treatment of both hypertension and pain associated with osteoarthritis.
- FDA Approves Consensi (amlodipine and celecoxib) for Treatment of Hypertension and Osteoarthritis Pain - May 31, 2018
- Kitov Announces Filing by FDA of New Drug Application for KIT-302 - October 2, 2017
- Kitov Submits New Drug Application to FDA for KIT-302 - July 31, 2017
- Kitov Updates on KIT-302 New Drug Application - June 26, 2017
Imvexxy (estradiol) Vaginal Inserts - formerly TX-004HR
Company: TherapeuticsMD, Inc.
Date of Approval: May 29, 2018
Treatment for: Dyspareunia
Imvexxy (estradiol) is a bio-identical 17β-estradiol vaginal insert for the treatment of dyspareunia (vaginal pain during sexual intercourse) due to menopause.
- TherapeuticsMD Announces FDA Approval of Imvexxy (estradiol vaginal inserts) for the Treatment of Dyspareunia Due to Menopause - May 30, 2018
- TherapeuticsMD Announces FDA Acceptance of New Drug Application and Prescription Drug User Fee Act (PDUFA) Date for TX-004HR - December 19, 2017
- TherapeuticsMD Announces Resubmission of New Drug Application for TX-004HR - November 29, 2017
- TherapeuticsMD Receives Complete Response Letter from FDA for TX-004HR New Drug Application - May 8, 2017
- TherapeuticsMD Provides Additional Information on TX-004HR Regulatory Update - April 19, 2017
- TherapeuticsMD Provides TX-004HR Regulatory Update - April 10, 2017
- TherapeuticsMD Announces FDA Acceptance of New Drug Application (NDA) and Prescription Drug User Fee Act (PDUFA) Date for Yuvvexy (TX-004HR) - September 19, 2016
- TherapeuticsMD Announces New Drug Application Submission for Yuvvexy (TX-004HR) - July 7, 2016
Palynziq (pegvaliase-pqpz) Injection
Company: BioMarin Pharmaceutical Inc.
Date of Approval: May 24, 2018
Treatment for: Phenylketonuria
Palynziq (pegvaliase-pqpz) is a phenylalanine-metabolizing enzyme indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria.
- FDA Approves Palynziq (pegvaliase-pqpz) for the Treatment of Adults with Phenylketonuria - May 24, 2018
Yonsa (abiraterone acetate) Tablets
Company: Sun Pharmaceutical Industries Inc.
Date of Approval: May 22, 2018
Treatment for: Prostate Cancer
Yonsa (abiraterone acetate) is an ultramicrosize formulation of the oral CYP17 inhibitor abiraterone acetate (approved as Zytiga) used in combination with methylprednisolone for the treatment of metastatic castration-resistant prostate cancer.
- Sun Pharma Announces FDA Approval of Yonsa (abiraterone acetate) to Treat Metastatic Castration-Resistant Prostate Cancer - May 23, 2018
- Churchill Pharmaceuticals Announces NDA Filing Acceptance for Yonsa by the U.S. FDA - July 20, 2017
- Churchill Pharmaceuticals Announces Submission of NDA for Yonsa (abiraterone acetate) Novel Oral Formulation of Prostate Cancer Treatment - May 23, 2017
Doptelet (avatrombopag) Tablets
Company: Dova Pharmaceuticals, Inc.
Date of Approval: May 21, 2018
Treatment for: Thrombocytopenia
Doptelet (avatrombopag) is a second generation, orally administered thrombopoietin receptor agonist (TPO-RA) indicated for the treatment of thrombocytopenia in patients with chronic liver disease who are scheduled to undergo a medical procedure.
- FDA Approves Doptelet (avatrombopag) for Chronic Liver Disease Patients with Thrombocytopenia who are Undergoing a Medical Procedure - May 21, 2018
- Dova Pharmaceuticals Announces FDA Acceptance of the Avatrombopag New Drug Application (NDA) with Priority Review - November 27, 2017
- Dova Pharmaceuticals Announces New Drug Application Submission to FDA for Avatrombopag, a Second Generation Thrombopoietin Receptor Agonist - September 22, 2017
Lokelma (sodium zirconium cyclosilicate) for Oral Suspension - formerly ZS-9
Company: AstraZeneca
Date of Approval: May 18, 2018
Treatment for: Hyperkalemia
Lokelma (sodium zirconium cyclosilicate) is a potassium binder indicated for the treatment of hyperkalemia in adults.
- FDA Approves Lokelma (sodium zirconium cyclosilicate) for the Treatment of Adults with Hyperkalemia - May 18, 2018
- AstraZeneca Receives Complete Response Letter from US FDA for ZS-9 (sodium zirconium cyclosilicate) for Hyperkalemia - March 17, 2017
- FDA Accepts for Review New Drug Application for Sodium Zirconium Cyclosilicate (ZS-9) for the Treatment of Hyperkalemia - October 18, 2016
- AstraZeneca Receives Complete Response Letter from FDA for Sodium Zirconium Cyclosilicate (ZS-9) for Hyperkalemia - May 27, 2016
- ZS Pharma Announces FDA Acceptance of ZS-9 New Drug Application - July 29, 2015
- ZS Pharma Submits NDA for ZS-9 for the Treatment of Hyperkalemia - May 26, 2015
Aimovig (erenumab-aooe) Injection
Company: Amgen Inc.
Date of Approval: May 17, 2018
Treatment for: Migraine Prophylaxis
Aimovig (erenumab-aooe) is a calcitonin gene-related peptide (CGRP) receptor antagonist indicated for the preventive treatment of migraine.
- FDA Approves Aimovig (erenumab-aooe) as a Preventive Treatment for Migraine - May 17, 2018
- FDA Accepts Biologics License Application for Aimovig (erenumab) - July 20, 2017
- Amgen Submits Biologics License Application to the FDA for Erenumab - May 18, 2017
Lucemyra (lofexidine hydrochloride) Tablets
Company: US WorldMeds
Date of Approval: May 16, 2018
Treatment for: Opiate Withdrawal
Lucemyra (lofexidine hydrochloride) is a selective alpha 2-adrenergic receptor agonist indicated for reducing the severity of withdrawal symptoms in patients experiencing opioid withdrawal.
- FDA Approves Lucemyra (lofexidine hydrochloride) as the First Non-Opioid Treatment for Management of Opioid Withdrawal Symptoms - May 16, 2018
- FDA Advisory Committee Votes in Favor of Lucemyra (lofexidine) for the Mitigation of Opioid Withdrawal Symptoms - March 27, 2018
- U.S. FDA Accepts Regulatory Submission and Grants Priority Review for US WorldMeds' Lofexidine - November 21, 2017
Retacrit (epoetin alfa-epbx) for Injection
Company: Hospira, Inc.
Date of Approval: May 15, 2018
Treatment for: Anemia
Retacrit (epoetin alfa-epbx) is an erythropoiesis-stimulating agent (ESA) biosimilar to Epogen/Procrit (epoetin alfa) indicated for treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery.
- FDA Approves Retacrit (epoetin alfa-epbx) as First Epoetin Alfa Biosimilar for the Treatment of Anemia - May 15, 2018
Plenvu (polyethylene glycol 3350 with electrolytes) for Oral Solution
Company: Salix Pharmaceuticals, Inc.
Date of Approval: May 4, 2018
Treatment for: Bowel Preparation
Plenvu (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride) is a lower-volume, polyethylene glycol based osmotic laxative indicated for cleansing of the colon (bowel preparation) prior to colonoscopy.
- Salix Receives FDA Approval for Plenvu, Next Generation 1-Liter Bowel Cleansing Preparation for Colonoscopies - May 7, 2018
- Salix Provides Update on FDA Submission for Plenvu - February 9, 2018
- Salix Announces Filing Acceptance for Plenvu Next Generation Bowel Cleansing Preparation for Colonoscopies - June 28, 2017
Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo)
Company: Portola Pharmaceuticals, Inc.
Date of Approval: May 3, 2018
Treatment for: Reversal of Anticoagulant Activity of Factor Xa Inhibitors
Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo) is a recombinant modified human Factor Xa (FXa) protein indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
- FDA Approves Portola Pharmaceuticals’ Andexxa, First and Only Antidote for the Reversal of Factor Xa Inhibitors - May 3, 2018
- Portola Pharmaceuticals Receives Complete Response Letter from FDA for Biologics License Application for AndexXa (andexanet alfa) - August 18, 2016
- Portola Pharmaceuticals Announces BLA for Andexanet Alfa Accepted for Review by FDA - February 17, 2016
- Portola Pharmaceuticals Completes BLA Submission to U.S. Food and Drug Administration for Andexanet Alfa - December 18, 2015
Jynarque (tolvaptan) Tablets
Company: Otsuka Pharmaceutical Co., Ltd
Date of Approval: April 23, 2018
Treatment for: Adults at Risk of Rapidly Progressing Autosomal Dominant Polycystic Kidney Disease
Jynarque (tolvaptan) is a selective vasopressin V2-receptor antagonist indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
- FDA Approves Jynarque (tolvaptan) to Slow Kidney Function Decline in Rapidly Progressing Autosomal Dominant Polycystic Kidney Disease - April 24, 2018
Akynzeo for Injection (fosnetupitant and palonosetron)
Company: Helsinn Healthcare SA
Date of Approval: April 19, 2018
Treatment for: Nausea/Vomiting -- Chemotherapy Induced
Akynzeo for Injection (fosnetupitant and palonosetron) is a substance P/neurokinin-1 (NK-1) receptor antagonist and serotonin-3 (5-HT3) receptor antagonist combination indicated for use with dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV).
- FDA Approves Intravenous Formulation of Akynzeo (fosnetupitant/palonosetron) for Chemotherapy-Induced Nausea and Vomiting - April 20, 2018
Crysvita (burosumab-twza) Injection
Company: Ultragenyx Pharmaceutical Inc.
Date of Approval: April 17, 2018
Treatment for: X-Linked Hypophosphatemia
Crysvita (burosumab-twza) is a fibroblast growth factor 23 (FGF23) blocking antibody for the treatment of x-linked hypophosphatemia (XLH).
- FDA Approves Crysvita (burosumab-twza) for X-Linked Hypophosphatemia - April 17, 2018
- Ultragenyx and Kyowa Hakko Kirin Announce FDA Acceptance and Priority Review Designation of Burosumab Biologics License Application - October 10, 2017
- Ultragenyx and Kyowa Hakko Kirin Announce Submission of Burosumab Biologics License Application in the US - August 24, 2017
Tavalisse (fostamatinib) Tablets
Company: Rigel Pharmaceuticals, Inc.
Date of Approval: April 17, 2018
Treatment for: Idiopathic (Immune) Thrombocytopenic Purpura
Tavalisse (fostamatinib) is an oral spleen tyrosine kinase (SYK) inhibitor for the treatment of patients with chronic immune thrombocytopenia (ITP).
- FDA Approves Tavalisse (fostamatinib disodium hexahydrate) for Chronic Immune Thrombocytopenia - April 17, 2018
- Rigel Provides Update on FDA Review of Fostamatinib for ITP - October 2, 2017
- FDA Accepts Rigel's New Drug Application for Tavalisse (fostamatinib disodium) for the Treatment of Chronic ITP - June 19, 2017
- Rigel Announces Tavalisse as Proprietary Name for Fostamatinib in the United States - April 27, 2017
- Rigel Submits New Drug Application to FDA for Fostamatinib in Chronic ITP - April 17, 2017
Symfi (efavirenz, lamivudine and tenofovir disoproxil fumarate) Tablets
Company: Mylan Pharmaceuticals Inc.
Date of Approval: March 22, 2018
Treatment for: HIV Infection
Symfi (efavirenz, lamivudine and tenofovir disoproxil fumarate) is a three-drug combination of a non-nucleoside reverse transcriptase inhibitor (efavirenz), and two nucleo(t)side reverse transcriptase inhibitors (lamivudine and tenofovir disoproxil fumarate) indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
- Mylan Introduces Symfi (efavirenz, lamivudine and tenofovir disoproxil fumarate) Triple Combo Once-Daily HIV Treatment in the U.S. - March 28, 2018
FDA Drug Approvals Archive
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