New Drug Approvals
The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.
Kabiven (amino acids, electrolytes, dextrose and lipid) Injectable Emulsion
Company: Fresenius Kabi USA
Date of Approval: August 25, 2014
Treatment for: Parenteral Nutrition
Kabiven (amino acids, electrolytes, dextrose and lipid injectable emulsion) is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition.
- Fresenius Kabi Receives FDA Approval for Kabiven and Perikabiven - August 27, 2014
Triumeq (abacavir, dolutegravir and lamivudine) Tablets
Company: ViiV Healthcare
Date of Approval: August 22, 2014
Treatment for: HIV Infection
Triumeq (abacavir, dolutegravir and lamivudine) is a fixed-dose combination containing the INSTI dolutegravir and the NRTIs abacavir and lamivudine for the treatment of HIV-1 infection.
- FDA Approves Triumeq (abacavir, dolutegravir and lamivudine) for the Treatment of HIV-1 Infection - August 22, 2014
Arnuity Ellipta (fluticasone furoate) Inhalation Powder
Company: GlaxoSmithKline plc
Date of Approval: August 20, 2014
Treatment for: Asthma, Asthma -- Maintenance
Arnuity Ellipta (fluticasone furoate inhalation powder) is a once-daily inhaled corticosteroid for the maintenance treatment of asthma.Arnuity Ellipta FDA Approval History
Cerdelga (eliglustat) Capsules
Company: Genzyme Corporation
Date of Approval: August 19, 2014
Treatment for: Gaucher Disease
Cerdelga (eliglustat) is a glucosylceramide synthase inhibitor indicated for the long- term treatment of adult patients with Gaucher disease type 1.
- FDA Approves Cerdelga (eliglustat) for Type 1 Gaucher Disease - August 19, 2014
- FDA Grants Priority Review for Genzyme’s Cerdelga (eliglustat), an Investigational Oral Therapy for Gaucher Disease - December 11, 2013
Plegridy (peginterferon beta-1a) Injection
Company: Biogen Idec
Date of Approval: August 15, 2014
Treatment for: Multiple Sclerosis
Plegridy (peginterferon beta-1a) is a pegylated interferon beta indicated for the treatment of patients with relapsing forms of multiple sclerosis.
- FDA Approves Plegridy (peginterferon beta-1a) for the Treatment of Multiple Sclerosis - August 18, 2014
- US and EU Regulatory Authorities Accept Plegridy (peginterferon beta-1a) Marketing Applications for Review - July 19, 2013
- Biogen Idec Submits Application to FDA for Approval of Plegridy (Peginterferon Beta-1a) in Multiple Sclerosis - May 21, 2013
Belsomra (suvorexant) Tablets
Company: Merck, Sharpe & Dohme Corp.
Date of Approval: August 13, 2014
Treatment for: Insomnia
Belsomra (suvorexant) is an orexin receptor antagonist for use in patients with difficulty falling or staying asleep (insomnia).
- FDA Approves Belsomra (suvorexant) for Insomnia - August 13, 2014
- Merck Receives Complete Response Letter for Suvorexant, Merck’s Investigational Medicine for Insomnia - July 1, 2013
- Merck Statement on FDA Advisory Committee Meeting for Suvorexant - May 22, 2013
- Merck Announces FDA Acceptance of New Drug Application for Suvorexant, an Investigational Insomnia Medicine - November 8, 2012
Invokamet (canagliflozin and metformin)
Company: Janssen Research & Development, LLC
Date of Approval: August 8, 2014
Treatment for: Diabetes Type 2
Invokamet (canagliflozin/metformin) is a selective sodium glucose co-transporter 2 (SGLT2) inhibitor and biguanide combination for the treatment of type 2 diabetes.
- FDA Approves Invokamet (canagliflozin/metformin) for Type 2 Diabetes - August 11, 2014
- FDA Issues Complete Response Letter for Canagliflozin/Metformin Fixed-Dose Combination Therapy for Type 2 Diabetes - December 12, 2013
- Janssen Research & Development Submits New Drug Application to U.S. FDA for Canagliflozin/Metformin Fixed-Dose Combination Therapy to Treat Patients with Type 2 Diabetes - December 12, 2012
Orbactiv (oritavancin) Injection
Company: The Medicines Company
Date of Approval: August 6, 2014
Treatment for: Skin and Structure Infection
Orbactiv (oritavancin) is a semi-synthetic lipoglycopeptide antibiotic for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
- FDA Approves Orbactiv (oritavancin) to Treat Skin and Skin Structure Infections - August 6, 2014
- FDA Accepts Filing of NDA for IV Antibiotic Oritavancin with Priority Review - February 20, 2014
- FDA Issues Complete Response Letter for Oritavancin - December 9, 2008
- Targanta Announces Review of Oritavancin at FDA Anti-Infective Drugs Advisory Committee Meeting - October 15, 2008
- Targanta Announces FDA Acceptance of Oritavancin New Drug Application - April 9, 2008
- Targanta Submits Oritavancin New Drug Application - February 11, 2008
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Date of Approval: August 1, 2014
Treatment for: Diabetes Type 2
Jardiance (empagliflozin) is a sodium glucose co-transporter-2 (SGLT2) inhibitor for the treatment of type 2 diabetes.
- FDA Approves Jardiance (empagliflozin) to Treat Type 2 Diabetes - August 1, 2014
- Boehringer Ingelheim and Eli Lilly and Company Announce Resubmission of NDA for Empagliflozin to FDA - June 17, 2014
- U.S. Food and Drug Administration Issues Complete Response Letter for Empagliflozin - March 5, 2014
- Boehringer Ingelheim, Lilly Submit NDA for Empagliflozin - March 29, 2013
Striverdi Respimat (olodaterol)
Company: Boehringer Ingelheim Pharmaceuticals Inc.
Date of Approval: July 31, 2014
Treatment for: Chronic Obstructive Pulmonary Disease
Striverdi Respimat (olodaterol) is a once-daily, long-acting beta-agonist (LABA) for the maintenance treatment of chronic obstructive pulmonary disease (COPD).
- FDA Approves Striverdi Respimat to Treat Chronic Obstructive Pulmonary Disease - July 31, 2014
- FDA Advisory Committee Recommends Approval for Boehringer Ingelheim's Olodaterol for Maintenance Treatment of COPD - January 30, 2013
Acticlate (doxycycline hyclate) Tablets
Company: Aqua Pharmaceuticals, LLC
Date of Approval: July 25, 2014
Treatment for: Bacterial Infection, Acne
Acticlate (doxycycline hyclate) is a tetracycline-class antibacterial indicated for the treatment of a number of infections, including adjunctive therapy in severe acne.
- Aqua Pharmaceuticals Announces FDA Approval of Acticlate (doxycycline hyclate USP) Tablets - July 28, 2014
Zydelig (idelalisib) Tablets
Company: Gilead Sciences, Inc.
Date of Approval: July 23, 2014
Treatment for: non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Follicular Lymphoma
Zydelig (idelalisib) is a phosphoinositide 3-kinase (PI3K) delta inhibitor for the treatment of chronic lymphocytic leukemia, relapsed follicular B-cell non-Hodgkin lymphoma, and relapsed small lymphocytic lymphoma.
- FDA Approves Zydelig (idelalisib) for CLL and Lymphoma - July 23, 2014
- U.S. FDA Accepts New Drug Application for Gilead’s Idelalisib for the Treatment of Refractory Indolent Non-Hodgkin’s Lymphoma - January 13, 2014
- Gilead Submits New Drug Application to U.S. FDA for Idelalisib for the Treatment of Indolent Non-Hodgkin's Lymphoma - September 11, 2013
Targiniq ER (naloxone and oxycodone) Extended-Release Tablets
Company: Purdue Pharma L.P.
Date of Approval: July 23, 2014
Treatment for: Pain
Targiniq ER (naloxone and oxycodone) is an opioid antagonist and opioid analgesic combination in a long-acting abuse-deterrent formulation for the management of chronic severe pain.
- FDA Approves Targiniq ER Extended-Release Oxycodone with Abuse-Deterrent Properties - July 23, 2014
- FDA Accepts for Review Purdue Pharma’s New Drug Application for Targiniq ER (oxycodone HCl/naloxone HCL Controlled-Release) Tablets CII - November 26, 2013
Flonase Allergy Relief (fluticasone propionate) Nasal Spray
Company: GlaxoSmithKline plc
Date of Approval: July 23, 2014
Treatment for: Allergic Rhinitis
Flonase Allergy Relief (fluticasone propionate) is a once-a-day, over-the-counter corticosteroid nasal spray indicated for the relief hay fever symptoms.Flonase Allergy Relief FDA Approval History
Ryanodex (dantrolene) Injectable Suspension
Company: Eagle Pharmaceuticals, Inc.
Date of Approval: July 22, 2014
Treatment for: Malignant Hyperthermia
Ryanodex (dantrolene) is a skeletal muscle relaxant in a concentrated formulation for the treatment of malignant hyperthermia.
- FDA Approves Ryanodex for the Treatment of Malignant Hyperthermia - July 23, 2014
- NDA for Orphan Drug Ryanodex Accepted By FDA - March 20, 2014
Ruconest (C1 esterase inhibitor (recombinant)) - formerly Rhucin
Company: Pharming Group NV
Date of Approval: July 16, 2014
Treatment for: Angioedema
Ruconest is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).
- FDA Approves Ruconest for Hereditary Angioedema - July 17, 2014
- Santarus and Pharming Announce Receipt of FDA Refusal to File Letter for Rhucin Biologics License Application - February 28, 2011
- Pharming And Santarus Announce Submission Of Rhucin Biologics License Application to FDA - December 28, 2010
- Pharming Provides Update on Rhucin - January 29, 2008
Rasuvo (methotrexate) Injection - formerly MPI-2505
Company: Medac Pharma, Inc.
Date of Approval: July 11, 2014
Treatment for: Rheumatoid Arthritis, Juvenile Rheumatoid Arthritis, Psoriasis
Rasuvo (methotrexate) is a subcutaneous, ready-to-use autopen formulation of methotrexate for the treatment of rheumatoid arthritis (RA), poly-articular-course juvenile RA and psoriasis.
- FDA Approves Rasuvo (methotrexate) Injection - July 14, 2014
- Medac Pharma, Inc. Secures FDA Acceptance of a New Drug Application (NDA) for Methotrexate-Containing Autopen - January 27, 2014
Kerydin (tavaborole) Topical Solution
Company: Anacor Pharmaceuticals
Date of Approval: July 7, 2014
Treatment for: Onychomycosis -- Toenail
Kerydin (tavaborole) is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails.
- FDA Approves Kerydin (tavaborole) Topical Solution for Onychomycosis of the Toenails - July 8, 2014
- Anacor Pharmaceuticals Announces FDA Acceptance of Tavaborole NDA for Filing - October 3, 2013
- Anacor Pharmaceuticals Announces That It Has Submitted a New Drug Application to the FDA for Tavaborole - July 29, 2013
Beleodaq (belinostat) Injection
Company: Spectrum Pharmaceuticals, Inc.
Date of Approval: July 3, 2014
Treatment for: Peripheral T-cell Lymphoma
Beleodaq (belinostat) is a histone deacetylase (HDAC) inhibitor for the treatment of peripheral T-cell lymphoma (PTCL).
- FDA Approves Beleodaq (belinostat) for Peripheral T-Cell Lymphoma - July 3, 2014
- Spectrum Pharmaceuticals Announces FDA's Acceptance of NDA Filing for Beleodaq (belinostat) for Injection, a novel pan-HDAC inhibitor - February 6, 2014
- New Drug Application for Belinostat in Relapsed or Refractory PTCL Submitted to the FDA - December 10, 2013
Afrezza (insulin human [rDNA origin]) Inhalation Powder - formerly Afresa
Company: MannKind Corporation
Date of Approval: June 27, 2014
Treatment for: Diabetes Type 1, Diabetes Type 2
Afrezza (insulin human [rDNA origin]) is a rapid acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus.
- FDA Approves Afrezza to Treat Diabetes - June 27, 2014
- MannKind Updates Status of New Drug Application for Afrezza - April 7, 2014
- FDA Advisory Committee Recommends Approval of Afrezza - Investigational Drug to Treat Diabetes - April 2, 2014
- MannKind Resubmits New Drug Application to U.S. FDA for Afrezza for the Treatment of Adults with Diabetes - October 14, 2013
- MannKind Reports Positive Data from a Phase 3 Clinical Study of Afrezza in Patients with Type 1 Diabetes - August 14, 2013
- MannKind Confirms Design of Pivotal Studies for Afrezza - August 12, 2011
- MannKind Corporation Receives Complete Response Letter from the FDA for Afrezza - January 20, 2011
- MannKind Updates Status of New Drug Application for Afrezza - December 28, 2010
- FDA Accepts Afrezza Complete Response Resubmission and Sets Target Action Date - July 20, 2010
- FDA Requests Additional Information Regarding Afrezza in Complete Response Letter to MannKind - March 15, 2010
- MannKind Updates Status of Afrezza New Drug Application - January 13, 2010
- Emisphere Technologies Receives Milestone Payment from MannKind Corporation - May 21, 2009
- MannKind Submits NDA for Afresa for Treatment of Diabetes - March 16, 2009