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New Drug Approvals Archive - July 2013

July 2013

July 1	Latuda (lurasidone) New Indication Approved: June 28, 2013 Sunovion Pharmaceuticals Inc. Announces FDA Approval of Latuda (lurasidone HCl) as Monotherapy and Adjunctive Therapy in Adult Patients with Bipolar Depression Latuda (lurasidone) FDA Approval History
July 2	Isentress (raltegravir) Labeling Revision Approved: June 28, 2013 FDA Approves New U.S. Labeling for Isentress (raltegravir) to Include 240-Week Results from STARTMRK Study of Isentress Containing Regimen in Previously Untreated HIV-1 Infected Adult Patient Isentress (raltegravir) FDA Approval History
July 3	Zubsolv (buprenorphine and naloxone) Sublingual Tablets Date of Approval: July 3, 2013 Company: Orexo AB Treatment for: Opiate Dependence Zubsolv (buprenorphine and naloxone) is a sublingual partial opioid agonist indicated for the maintenance treatment of opioid dependence. FDA Approves Zubsolv for the Maintenance Treatment of Opioid Dependence Zubsolv (buprenorphine and naloxone) FDA Approval History
July 10	Khedezla (desvenlafaxine) Extended-Release Tablets Date of Approval: July 10, 2013 Company: Osmotica Pharmaceutical Corp. Treatment for: Depression Khedezla (desvenlafaxine) is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of major depressive disorder. FDA Approves Khedezla for Major Depressive Disorder Khedezla (desvenlafaxine) FDA Approval History
July 12	Gilotrif (afatinib) Tablets Date of Approval: July 12, 2013 Company: Boehringer Ingelheim Pharmaceuticals Inc. Treatment for: Non-Small Cell Lung Cancer Gilotrif (afatinib) is a kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC). FDA Approves Gilotrif for Late Stage Non-Small Cell Lung Cancer Gilotrif (afatinib) FDA Approval History
July 19	Simponi (golimumab) New Dosage Form Approved: July 18, 2013 Simponi Aria (golimumab) for Infusion Receives FDA Approval for Treatment of Moderately to Severely Active Rheumatoid Arthritis Simponi (golimumab) FDA Approval History
July 19	Astagraf XL (tacrolimus) Extended-Release Capsules Date of Approval: July 19, 2013 Company: Astellas Pharma US, Inc. Treatment for: Organ Transplant -- Rejection Prophylaxis Astagraf XL (tacrolimus) is a calcineurin-inhibitor immunosuppressant for the prophylaxis of organ rejection in patients receiving a kidney transplant. Astellas Announces FDA Approval of Astagraf XL (tacrolimus extended-release capsules) for the Prophylaxis of Organ Rejection Astagraf XL (tacrolimus) FDA Approval History
July 24	Lo Minastrin Fe (ethinyl estradiol and norethindrone, ethinyl estradiol, and ferrous fumarate) Tablets Date of Approval: July 24, 2013 Company: Warner Chilcott plc Treatment for: Contraception Lo Minastrin Fe (ethinyl estradiol and norethindrone, ethinyl estradiol, and ferrous fumarate) is an estrogen/progestin combined oral contraceptive indicated for use by women to prevent pregnancy. Warner Chilcott Announces FDA Approval of Lo Minastrin Fe Lo Minastrin Fe (ethinyl estradiol and norethindrone, ethinyl estradiol, and ferrous fumarate) FDA Approval History
July 25	Injectafer (ferric carboxymaltose) Injection Date of Approval: July 25, 2013 Company: Luitpold Pharmaceuticals, Inc. Treatment for: Iron Deficiency Anemia Injectafer (ferric carboxymaltose) is an iron replacement product indicated for the treatment of iron deficiency anemia. FDA Approves Injectafer for Iron Deficiency Anemia Injectafer (ferric carboxymaltose) FDA Approval History
July 25	Fetzima (levomilnacipran) Extended-Release Capsules Date of Approval: July 25, 2013 Company: Allergan, Inc. Treatment for: Depression Fetzima (levomilnacipran) is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of major depressive disorder. Forest Laboratories and Pierre Fabre Laboratories Announce FDA Approval of Fetzima for the Treatment of Major Depressive Disorder in Adults Fetzima (levomilnacipran) FDA Approval History
December 12	Zubsolv (buprenorphine and naloxone) New Dosage Form Approved: December 11, 2014 FDA Approves Two Higher Dosage Strengths of Zubsolv Zubsolv (buprenorphine and naloxone) FDA Approval History
August 11	Zubsolv (buprenorphine and naloxone) New Indication Approved: August 10, 2015 FDA Approves Zubsolv for Induction of Buprenorphine Maintenance Therapy in Patients Suffering from Opioid Dependence Zubsolv (buprenorphine and naloxone) FDA Approval History
April 15	Gilotrif (afatinib) New Indication Approved: April 15, 2016 FDA Approves Gilotrif (afatinib) for Patients with Squamous Cell Carcinoma of the Lung Gilotrif (afatinib) FDA Approval History
July 3	Zubsolv (buprenorphine and naloxone) Sublingual Tablets Date of Approval: July 3, 2013 Company: Orexo AB Treatment for: Opiate Dependence Zubsolv (buprenorphine and naloxone) is a sublingual partial opioid agonist indicated for the maintenance treatment of opioid dependence. FDA Approves Unique Low Dosage of Zubsolv Zubsolv (buprenorphine and naloxone) FDA Approval History

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