SPOTLIGHT -
FDA actions in brief, July 2009 (Besivance, Taxus Liberte Atom Stent System, Risperdal Consta, Prograf, Zipsor, Sprycel, Axert, Caldolor, Lamictal XR)
Recent FDA approvals (through July 2009) related to Besivance, Taxus Liberte Atom Stent System, Risperdal Consta, Prograf, Zipsor, Sprycel, Axert, Caldolor, and Lamictal XR
First-time generic drug approval, July 2009
Generic drug approved by FDA (through July 2009): melphalan injection
Tadalafil (Adcirca): Phosphodiesterase type 5 inhibitor approved for the treatment of pulmonary arterial hypertension (WHO Group I)
New indication: Tadalafil (Adcirca), a phosphodiesterase type 5 inhibitor, was approved on May 22, 2009, for the treatment of pulmonary arterial hypertension (WHO Group I)
Tolvaptan (Samsca): Vasopressin receptor antagonist approved for the treatment of clinically significant hypervolemic and euvolemic hyponatremia
New molecular entity: Tolvaptan (Samsca), a vasopressin receptor antagonist, was approved on May 19, 2009, for the treatment of clinically significant hypervolemic and euvolemic hyponatremia
Zoledronic acid (Reclast): Bisphosphonate approved for the prevention of osteoporosis in postmenopausal women
New indication: Zoledronic acid (Reclast), a bisphosphonate, was approved on May 29, 2009, for the prevention of osteoporosis in postmenopausal women
First-time generic drug approvals, May 2009
Generic drugs approved by FDA (through May 2009) including drospirenone and ethinyl estradiol, levalbuterol, and topiramate
FDA actions in brief, May 2009 (Coartem, Ixiaro, Lexapro, Reclast, Symbyax)
Recent FDA approvals (through May 2009) related to Coartem, Ixiaro, Lexapro, Reclast, and Symbyax
Tigecycline (Tygacil): Tetracycline-class antibiotic approved for the treatment of community-acquired bacterial pneumonia
New indication: Tigecycline (Tygacil), a tetracycline-class antibiotic, was approved on March 20, 2009, for the treatment of community-acquired bacterial pneumonia
Everolimus (Afinitor): Antineoplastic agent approved for the treatment of advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib
New molecular entity: Everolimus (Afinitor), an antineoplastic agent, was approved on March 30, 2009, for the treatment of advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib
First-time generic drug approvals, April 2009
Generic drugs approved by FDA (through April 2009) including malathion lotion, 0.5%
FDA actions in brief, April 2009 (PegIntron, Rebetol, Apidra SoloSTAR, Temodar, Copaxone, Edluar)
Recent FDA approvals (through April 2009) related to PegIntron, Rebetol, Apidra SoloSTAR, Temodar, Copaxone, and Edluar
Budesonide/Formoterol (Symbicort): Corticosteroid/LABA combination approved for the maintenance treatment of COPD
New indication: Budesonide/formoterol (Symbicort), a corticosteroid/LABA combination, was approved on February 27, 2009, for the maintenance treatment of COPD
First-time generic drug approvals, March 2009
Generic drugs approved by FDA (through March 2009) including sumatriptan tablets, divalproex extended-release tablets, and risperidone oral solution
Antithrombin (recombinant) (ATryn): Recombinant human antithrombin approved for the prevention of perioperative and peripartum thromboembolic events in hereditary antithrombin-deficient patients
New biologic: Antithrombin (recombinant) (ATryn), a recombinant human antithrombin, was approved on February 6, 2009, for the prevention of perioperative and peripartum thromboembolic events in hereditary antithrombin-deficient patients
Febuxostat (Uloric): Xanthine oxidase inhibitor approved for chronic management of hyperuricemia in patients with gout
FDA actions in brief, February 2009 (Vasovist, Lusedra, Zingo, Latisse, Gleevec, Nexterone, Zolpimist, Trilipix, Ryzolt, Epiduo, AllerNaze)
Recent FDA approvals (through Feburary 2009) related to Vasovist, Lusedra, Zingo, Latisse, Gleevec, Nexterone, Zolpimist, Trilipix, Ryzolt, Epiduo, and AllerNaze
Degarelix: GnRH receptor antagonist approved for the treatment of advanced prostate cancer
New molecular entity: Degarelix, a GnRH receptor antagonist, was approved on December 24, 2008, for the treatment of advanced prostate cancer
Milnacipran (Savella): Selective norepinephrine and serotonin reuptake inhibitor approved for the management of fibromyalgia
New molecular entity: Milnacipran (Savella), a selective norepinephrine and serotonin reuptake inhibitor, was approved on January 14, 2009, for the management of fibromyalgia
FDA actions in brief, January 2009 (Banzel, tapentadol, synthetic conjugated estrogens-A, Ranexa)
Recent FDA approvals (through January 2009) related to Banzel, tapentadol, synthetic conjugated estrogens-A, and Ranexa
Toviaz (fesoterodine): Muscarinic receptor antagonist approved for the treatment of overactive bladder
New molecular entity: Fesoterodine (Toviaz), a muscarinic receptor antagonist, was approved on October 31, 2008, for the treatment of overactive bladder
First-time generic drug approvals, December 2008
Generic drugs approved by FDA (through December 2008) including levetiracetam tablets, dorzolamide/timolol ophthalmic solution, and dorzolamide ophthalmic solution
Cinryze: C1 inhibitor approved for prophylaxis of angioedema attacks in patients with hereditary angioedema (HAE)
New biologic: C1 inhibitor (human) (Cinryze) was approved on October 10, 2008, for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema
Vimpat (lacosamide): Antiepileptic drug approved as adjunctive therapy for the treatment of partial-onset seizures in adults
New molecular entity: Lacosamide (Vimpat), an antiepileptic drug, was approved on October 28, 2008, as adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years or older
First-time generic drug approvals, November 2008
Generic drugs approved by FDA (through November 2008) including galantamine extended-release capsules and carbidopa/levodopa orally disintegrating tablets
FDA actions in brief, November 2008 (Gardasil, Gamunex, Alimta, Nasacort AQ, ProAir HFA, Keppra XR, Taxus Express2 Atom Paclitaxel-Eluting Coronary Stent System)
Recent FDA approvals (through November 2008) related to Gardasil, Gamunex, Alimta, Nasacort AQ, ProAir HFA, Keppra XR, and Taxus Express2 Atom Paclitaxel-Eluting Coronary Stent System
Granisetron transdermal system (Sancuso): Antinauseant/antiemetic agent approved for the prevention of chemotherapy-induced nausea and vomiting
FDA drug approvals
FDA actions in brief, October 2008 (Cancidas, Aloxi, Vidaza)
Recent FDA approvals and indications (through October 2008) related to Cancidas, Aloxi, and Vidaza.
Romiplostim (Nplate): Thrombopoietin mimetic peptibody approved for the treatment of chronic ITP
New biologic: Romiplostim (Nplate), a thrombopoietin mimetic peptibody, was approved on August 22, 2008, for the treatment of chronic ITP.
Tetrabenazine (Xenazine): Monoamine depleter approved for the treatment of chorea associated with Huntington's disease
New molecular entity: Tetrabenazine (Xenazine), a monoamine depleter, was approved on August 15, 2008, for the treatment of chorea associated with Huntington's disease.
First-time generic drug approvals, September 2008
Generic drugs approved by FDA (through September 2008) including nisoldipine extended-release tablets and divalproex delayed-release tablets