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New Drug Approvals Archive - March 2014

March 2014

March 3	Bydureon (exenatide) New Dosage Form Approved: March 3, 2014 FDA Approves Bydureon Pen for Once-Weekly Treatment of Adults with Type 2 Diabetes Bydureon (exenatide) FDA Approval History
March 5	Aveed (testosterone undecanoate) Intramuscular Injection - formerly Nebido Date of Approval: March 5, 2014 Company: Endo Pharmaceuticals Treatment for: Hypogonadism -- Male Aveed (testosterone undecanoate) is a long-acting androgen depot injection for the treatment of male hypogonadism. FDA Approves Aveed (testosterone undecanoate) Injectable Testosterone Replacement Therapy Aveed (testosterone undecanoate) FDA Approval History
March 11	Xartemis XR (acetaminophen and oxycodone hydrochloride) Extended-Release Tablets - formerly MNK-795 Date of Approval: March 11, 2014 Company: Mallinckrodt Treatment for: Pain Xartemis XR (acetaminophen and oxycodone hydrochloride) is an extended-release analgesic and opioid agonist formulation for the management of moderate to severe acute pain. FDA Approves Xartemis XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII) Xartemis XR (acetaminophen and oxycodone hydrochloride) FDA Approval History
March 11	Qudexy XR (topiramate) Extended-Release Capsules Date of Approval: March 11, 2014 Company: Upsher-Smith Laboratories, Inc. Treatment for: Seizures, Lennox-Gastaut Syndrome, Migraine Prophylaxis Qudexy XR (topiramate) is an antiepileptic drug indicated for the treatment of partial onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut Syndrome in adults and children; and for the prophylaxis of migraine headache in adults and adolescents. Upsher-Smith Receives FDA Approval for Qudexy XR (topiramate) Extended-Release Capsules Qudexy XR (topiramate) FDA Approval History
March 14	Noxafil (posaconazole) New Dosage Form Approved: March 13, 2014 FDA Approves Merck’s Noxafil (posaconazole) Injection Noxafil (posaconazole) FDA Approval History
March 14	Hemangeol (propranolol hydrochloride) Oral Solution Date of Approval: March 14, 2014 Company: Pierre Fabre Dermatologie Treatment for: Infantile Hemangioma Hemangeol (propranolol hydrochloride) is a pediatric beta-blocker formulation indicated for the treatment of proliferating infantile hemangioma. Pierre Fabre Obtains FDA Approval to Market Hemangeol for the Treatment of Infantile Hemangioma Hemangeol (propranolol hydrochloride) FDA Approval History
March 18	Eliquis (apixaban) New Indication Approved: March 13, 2014 FDA Approves Eliquis to Reduce Risk of Blood Clots Following Hip Or Knee Replacement Surgery Eliquis (apixaban) FDA Approval History
March 19	Impavido (miltefosine) Capsules Date of Approval: March 19, 2014 Company: Paladin Labs Inc. Treatment for: Leishmaniasis Impavido (miltefosine) is an oral alkylphosphocholine antiparasitic for the treatment of leishmaniasis. FDA Approves Impavido to Treat Tropical Disease Leishmaniasis Impavido (miltefosine) FDA Approval History
March 19	Neuraceq (florbetaben F18) Injection Date of Approval: March 19, 2014 Company: Piramal Imaging Treatment for: Positron Emission Tomography Imaging Neuraceq (florbetaben F18) is a radioactive diagnostic agent indicated for PET imaging of the brain to estimate β-amyloid neuritic plaquedensity in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. FDA Approves Neuraceq (florbetaben F18 injection) for PET Imaging of Beta-Amyloid Plaques Neuraceq (florbetaben F18) FDA Approval History
March 21	Otezla (apremilast) Tablets Date of Approval: March 21, 2014 Company: Celgene Corporation Treatment for: Psoriatic Arthritis, Plaque Psoriasis Otezla (apremilast) is a phosphodiesterase 4 (PDE4) inhibitor indicated for the treatment of psoriatic arthritis and plaque psoriasis. FDA Approves Otezla (apremilast) to Treat Psoriatic Arthritis Otezla (apremilast) FDA Approval History
March 21	Xolair (omalizumab) New Indication Approved: March 21, 2014 FDA Approves Xolair (omalizumab) for Chronic Idiopathic Urticaria
March 28	Topamax (topiramate) Patient Population Altered: March 28, 2014 FDA Approves Topamax for Migraine Prevention in Adolescents
March 28	Alprolix (coagulation factor IX (recombinant)) Date of Approval: March 28, 2014 Company: Biogen Idec, Inc. Treatment for: Hemophilia B Alprolix (coagulation factor IX (recombinant)) is a clotting factor IX therapy indicated to prevent bleeding in patients with hemophilia B. FDA Approves Alprolix (recombinant coagulation factor IX) for patients with Hemophilia B Alprolix (coagulation factor IX (recombinant)) FDA Approval History
March 31	Nexium (esomeprazole) New Formulation Approved: March 28, 2014 Pfizer Statement on U.S. FDA Approval of Over-the-Counter Nexium 24HR
September 23	Otezla (apremilast) New Indication Approved: September 23, 2014 FDA Approves Otezla (apremilast) for Moderate to Severe Plaque Psoriasis Otezla (apremilast) FDA Approval History
June 1	Qudexy XR (topiramate) Patient Population Altered: March 31, 2015 FDA Approves Expanded Indication for Qudexy XR (Topiramate) for Pediatric Patients Qudexy XR (topiramate) FDA Approval History
March 30	Qudexy XR (topiramate) New Indication Approved: March 29, 2017 FDA Approves Expanded Indication for Qudexy XR (topiramate) Extended-Release Capsules to Include Prophylaxis of Migraine Headache in Adults and Adolescents Qudexy XR (topiramate) FDA Approval History

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