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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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
Ilumya (tildrakizumab-asmn) Injection
Company: Sun Pharmaceutical Industries Inc.
Date of Approval: March 20, 2018
Treatment for: Plaque Psoriasis
Ilumya (tildrakizumab-asmn) is a humanized, anti-IL-23p19 monoclonal antibody for the treatment of moderate-to-severe plaque psoriasis.
- FDA Approves Ilumya (tildrakizumab-asmn) for the Treatment of Moderate-to-Severe Plaque Psoriasis - March 21, 2018
- Sun Pharma Announces US FDA Filing Acceptance of Biologics License Application (BLA) For Tildrakizumab - May 24, 2017
Trogarzo (ibalizumab-uiyk) Injection
Company: TaiMed Biologics USA Corp.
Date of Approval: March 6, 2018
Treatment for: HIV Infection
Trogarzo (ibalizumab-uiyk) is a CD4-directed post-attachment HIV-1 inhibitor for the treatment of multidrug resistant human immunodeficiency virus-1 (HIV-1) infection in heavily treatment-experienced adults.
- FDA Approves Trogarzo (ibalizumab-uiyk) for Treatment-Experienced Patients with Multidrug Resistant HIV - March 6, 2018
Cimduo (lamivudine and tenofovir disoproxil fumarate) Tablets
Company: Mylan Pharmaceuticals Inc.
Date of Approval: February 28, 2018
Treatment for: HIV Infection
Cimduo (lamivudine and tenofovir disoproxil fumarate) is a combination of two nucleo(t)side reverse transcriptase inhibitors indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
- Mylan to Introduce Cimduo (lamivudine and tenofovir disoproxil fumarate) as a New Cost-Saving HIV Combination Treatment in the U.S. - March 2, 2018
ZTlido (lidocaine) Patch - formerly Ztilido
Company: Scilex Pharmaceuticals, Inc.
Date of Approval: February 28, 2018
Treatment for: Postherpetic Neuralgia
ZTlido (lidocaine topical system 1.8%) is a transdermal anesthetic formulation for the treatment of pain associated with postherpetic neuralgia.
- Sorrento Therapeutics Subsidiary, Scilex, Receives FDA Approval for Non-Opioid ZTlido (lidocaine topical system) 1.8% for Post-Herpetic Neuralgia Pain - February 28, 2018
- FDA Acknowledges Receipt of Sorrento Therapeutics Inc, NDA for ZTlido - September 12, 2017
- Sorrento Therapeutics, Inc. Submits NDA For ZTlido Next-Generation Lidocaine Patch - August 29, 2017
- FDA Accepts Scilex Pharmaceuticals' NDA Filing for ZTlido - September 16, 2015
- Scilex Pharmaceuticals Initiates Pivotal Pharmacokinetic Study for Ztilido - May 15, 2014
- Scilex Pharmaceuticals Announces Filing of Investigational New Drug Application for Ztilido - March 24, 2014
Apadaz (acetaminophen and benzhydrocodone hydrochloride) Tablets - formerly KP201
Company: KemPharm, Inc.
Date of Approval: February 23, 2018
Treatment for: Pain
Apadaz (acetaminophen and benzhydrocodone hydrochloride) is an immediate release combination of acetaminophen and benzhydrocodone, a prodrug of the opioid agonist hydrocodone, indicated for the short-term management of acute pain.
- FDA Approves Apadaz (benzhydrocodone and acetaminophen) for the Short-Term Management of Acute Pain - February 23, 2018
- FDA Issues Complete Response Letter for Apadaz New Drug Application - June 13, 2016
- Statement Regarding FDA Advisory Committee Meeting on KemPharm’s Abuse-Deterrent Product Candidate Apadaz - May 5, 2016
Osmolex ER (amantadine hydrochloride) Extended-Release Tablets
Company: Osmotica Pharmaceutical US LLC
Date of Approval: February 20, 2018
Treatment for: Parkinson's Disease, Extrapyramidal Reaction
Osmolex ER (amantadine hydrochloride) is a proprietary formulation of immediate release and extended release amantadine for the once-a-day treatment of Parkinson’s disease and drug-induced extrapyramidal reactions.
- FDA Approves Osmolex ER (amantadine) for the treatment of Parkinson’s Disease and Drug-Induced Extrapyramidal Reactions - February 19, 2018
- Osmotica Announces OS-320 (Osmolex ER), Has Been Awarded Orphan Drug Status by the FDA - July 22, 2015
Erleada (apalutamide) Tablets
Company: Janssen Pharmaceuticals, Inc.
Date of Approval: February 14, 2018
Treatment for: Prostate Cancer
Erleada (apalutamide) is an oral androgen receptor inhibitor for the treatment of men with non-metastatic castration-resistant prostate cancer (CRPC).
- FDA Approves Erleada (apalutamide) for Non-Metastatic Castration-Resistant Prostate Cancer - February 14, 2018
- Janssen Submits New Drug Application to U.S. FDA for Apalutamide (ARN-509) to Treat Men with Non-Metastatic Castration-Resistant Prostate Cancer - October 11, 2017
Symdeko (ivacaftor/tezacaftor and ivacaftor) Tablets
Company: Vertex Pharmaceuticals Incorporated
Date of Approval: February 12, 2018
Treatment for: Cystic Fibrosis
Symdeko (ivacaftor/tezacaftor tablets and ivacaftor tablets) is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator and CFTR corrector combination for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have two copies of the F508del mutation, or who have at least one mutation in the CF gene that is responsive to treatment with Symdeko.
- FDA Approves Symdeko (tezacaftor/ivacaftor and ivacaftor) to Treat Cystic Fibrosis in People Ages 12 and Older with Certain Mutations in the CFTR Gene - February 12, 2018
- Vertex Announces Acceptance of its Applications for Review of the Tezacaftor/Ivacaftor Combination Treatment in People with Cystic Fibrosis by the FDA and EMA - August 24, 2017
Dexycu (dexamethasone) Intraocular Suspension
Company: Icon Bioscience Inc.
Date of Approval: February 9, 2018
Treatment for: Postoperative Ocular Inflammation
Dexycu (dexamethasone) is a long-acting, injectable corticosteroid formulation administered intraocularly into the posterior chamber of the eye for the treatment of postoperative inflammation associated with cataract surgery.
- Icon Bioscience Receives FDA Approval for Dexycu (dexamethasone intraocular suspension) for Treating Inflammation Associated With Cataract Surgery - February 12, 2018
- Icon Bioscience Submits NDA For Dexycu, a Potential Transformational Drug Therapy for Treating Inflammation Associated with Cataract Surgery - April 13, 2017
Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) Tablets
Company: Gilead Sciences, Inc.
Date of Approval: February 7, 2018
Treatment for: HIV Infection
Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) is an integrase strand transfer inhibitor and emtricitabine/tenofovir alafenamide (Descovy) combination for the treatment of HIV-1 infection in adults.
- FDA Approves Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) for Treatment of HIV-1 Infection - February 7, 2018
- 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
Symfi Lo (efavirenz, lamivudine and tenofovir disoproxil fumarate) Tablets
Company: Mylan Pharmaceuticals Inc.
Date of Approval: February 5, 2018
Treatment for: HIV Infection
Symfi Lo (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 to Introduce Symfi Lo (efavirenz, lamivudine and tenofovir disoproxil fumarate) as a New Cost-Saving HIV Combination Treatment in the U.S. - March 2, 2018
Firvanq (vancomycin hydrochloride) for Oral Solution
Company: CutisPharma
Date of Approval: January 26, 2018
Treatment for: Clostridium Difficile Associated Diarrhea; Enterocolitis
Firvanq (vancomycin hydrochloride) is an oral solution formulation of an approved tricyclic glycopeptide antibiotic for the treatment of Clostridium difficile associated diarrhea and Staphylococcus aureus enterocolitis.
- CutisPharma Announces FDA Approval of Firvanq (vancomycin) for Treatment of Clostridium Difficile Associated Diarrhea and Staphylococcus Aureus Colitis - January 29, 2018
Lutathera (lutetium Lu 177 dotatate) Injection
Company: Advanced Accelerator Applications S.A.
Date of Approval: January 26, 2018
Treatment for: Gastroenteropancreatic Neuroendocrine Tumors
Lutathera (lutetium Lu 177 dotatate) is a Lu-177-labeled somatostatin analogue indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.
- FDA Approves Lutathera (lutetium Lu 177 dotatate) for Gastroenteropancreatic Neuroendocrine Tumors - January 26, 2018
- Advanced Accelerator Applications Announces New Prescription Drug User Fee Act (PDUFA) date of January 26, 2018, for Lutetium Lu 177 Dotatate (Lutathera) - August 28, 2017
- Advanced Accelerator Applications Completes Resubmission of NDA for Lutetium Lu 177 Dotatate (Lutathera) to FDA - July 27, 2017
- Advanced Accelerator Applications Receives Complete Response Letter from FDA for Lutathera, an Investigational Treatment for Neuroendocrine Tumors - December 21, 2016
- Advanced Accelerator Applications Announces FDA Priority Review for Lutathera - June 27, 2016
Balcoltra (ethinyl estradiol/levonorgestrel and ferrous bisglycinate) Tablets
Company: Avion Pharmaceuticals, LLC
Date of Approval: January 9, 2018
Treatment for: Prevention of Pregnancy
Balcoltra (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets) is a progestin/estrogen combination oral contraceptive (COC) indicated for use by females of reproductive potential to prevent pregnancy.
- Avion Pharmaceuticals Announces FDA Approval of Balcoltra (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets) Oral Contraceptive - January 17, 2018
Lumify (brimonidine tartrate) Ophthalmic Solution
Company: Bausch & Lomb Inc.
Date of Approval: December 22, 2017
Treatment for: Ocular Redness
Lumify (brimonidine tartrate) is an over-the-counter (OTC) formulation of the alpha-adrenergic agonist brimonidine indicated for use in the treatment of ocular redness.
- Bausch + Lomb Receives FDA Approval of Lumify (brimonidine tartrate) Over-the-Counter Eye Drop for the Treatment of Eye Redness - December 22, 2017
Giapreza (angiotensin II) Injection - formerly LJPC-501
Company: La Jolla Pharmaceutical Company
Date of Approval: December 21, 2017
Treatment for: Hypotension, Shock
Giapreza (angiotensin II) is a synthetic human angiotensin II vasoconstrictor indicated for the treatment of hypotension in adults with septic or other distributive shock.
- FDA Approves Giapreza (angiotensin II) to Treat Dangerously Low Blood Pressure - December 21, 2017
- La Jolla Pharmaceutical Company Announces U.S. FDA Acceptance of New Drug Application for LJPC-501 - August 28, 2017
Macrilen (macimorelin) for Oral Solution
Company: Aeterna Zentaris, Inc.
Date of Approval: December 20, 2017
Treatment for: Diagnosis of Adult Growth Hormone Deficiency
Macrilen (macimorelin) is a growth hormone (GH) secretagogue receptor agonist indicated for the diagnosis of adult growth hormone deficiency.
- Aeterna Zentaris Announces FDA Approval of Macrilen (macimorelin) for Diagnosis of Adult Growth Hormone Deficiency - December 20, 2017
- 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
