Last week, I posted a list of new drugs approved in 2012. Again, as an FDA retiree formerly involved in the approval of new drugs, I am still very interested on what is new in FDA drug development this year.
FDA has been very busy this year so far. One medical device and more than sixty new drugs had been approved in eighteen therapeutic areas already for this mid year. In 2002 the year I retired FDA approved more than 100 new drugs that year. By the end of 2013, I predict that another 60 new drugs will be approved.
As a diabetic, I am quite delighted that two new drugs for type 2 diabetes are approved. These new drugs will be expensive, but we the patients have an an alternative options if we desire and believe these new drugs will have more benefits than risks in the cure of our malady. Congratulations to FDA and its employees for a good year so far.
1. Cardiology/Vascular Diseases
Kynamro (mipomersen sodium); Genzyme; For the treatment of homozygous familial hypercholesterolemia, Approved January 2013
Liptruzet (ezetimibe and atorvastatin); Merck; For the treatment of hyoerlipidemia, Approved May 2013
Nymalize (nimodipine); Arbor Pharmaceuticals; For the reduction of incidence and severity of ischemic deficits following subarachnoid hemorrhage, Approved May 2013
2. Dermatology
Sitavig (acyclovir) buccal tablets; BioAlliance Pharma; For the treatment of recurrent herpes labialis in adults, Approved April 2013
3.Devices
Breo Ellipta (fluticasone furoate and vilanterol inhalation powder); GlaxoSmithKline; For the treatment of chronic obstructive pulmonary disease, Approved May 2013
4. Endocrinology
Invokana (canagliflozin); Janssen Pharmaceuticals; For the treatment of type II diabetes mellitus, Approved April 2013
Nesina (alogliptin); Takeda; For the treatment of type II diabetes mellitus, Approved January 2013
Osphena (ospemifene); Shionogi; For the treatment of dyspareunia and vulvar and vaginal atrophy due to menopause, Approved March 2013
5. Family Medicine
Actemra ((ocilizumab); Genentech; For the treatment of Polyarticular Juvenile Idiopathic Arthritis, Approved May 2013
Breo Ellipta (fluticasone furoate and vilanterol inhalation powder); GlaxoSmithKline; For the treatment of chronic obstructive pulmonary disease, Approved May 2013
Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013
Ilaris (canakinumab); Novartis; For the treatment of Systemic Juvenile Idiopathic Arthritis, Approved May 2013
Invokana (canagliflozin); Janssen Pharmaceuticals; For the treatment of type II diabetes mellitus, Approved April 2013
Liptruzet (ezetimibe and atorvastatin); Merck; For the treatment of hyoerlipidemia, Approved May 2013
Nesina (alogliptin); Takeda; For the treatment of type II diabetes mellitus, Approved January 2013
Osphena (ospemifene); Shionogi; For the treatment of dyspareunia and vulvar and vaginal atrophy due to menopause, Approved March 2013
Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol); Teva Pharmaceutical; For the prevention of conception, Approved April 2013
Sitavig (acyclovir) buccal tablets; BioAlliance Pharma; For the treatment of recurrent herpes labialis in adults, Approved April 2013
Tecfidera (dimethyl fumarate); Biogen Idec; For the treatment of relapsing multiple sclerosis, Approved March 2013
Uceris (budesonide); Santarus; For the treatment of ulcerative colitis, Approved January 2013
6. Gastroenterology
Stivarga (regorafenib); Bayer; For the treatment of gastrointestinal stromal tumor, Approved February 2013
Uceris (budesonide); Santarus; For the treatment of ulcerative colitis, Approved January 2013
7. Genetic Disease
Kineret, anakinra; Swedish Orphan Biovitrum; For the treatment of Cryopyrin-Associated Periodic Syndromes, Approved January 2013
Kynamro (mipomersen sodium); Genzyme; For the treatment of homozygous familial hypercholesterolemia, Approved January 2013
Ravicti (glycerol phenylbutyrate); Hyperion Therapeutics; For the treatment of pediatrics and adults with urea cycle disorders, Approved February 2013
Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013
8. Hematology
Kcentra (Prothrombin Complex Concentrate); CSL Behring; For the reversal of vitamin K antagonist therapy-induced coagulation factor deficiency, Approved May 2013
Nymalize (nimodipine); Arbor Pharmaceuticals; For the reduction of incidence and severity of ischemic deficits following subarachnoid hemorrhage, Approved May 2013
Pomalyst (pomalidomide); Celgene; For the treatment of relapsed and refractory multiple myeloma, Approved February 2013
Ravicti (glycerol phenylbutyrate); Hyperion Therapeutics; For the treatment of pediatrics and adults with urea cycle disorders, Approved February 2013
9. Immunology
Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013
Kineret, anakinra; Swedish Orphan Biovitrum; For the treatment of Cryopyrin-Associated Periodic Syndromes, Approved January 2013
Sitavig (acyclovir) buccal tablets; BioAlliance Pharma; For the treatment of recurrent herpes labialis in adults, Approved April 2013
Tecfidera (dimethyl fumarate); Biogen Idec; For the treatment of relapsing multiple sclerosis, Approved March 2013
VariZIG, Varicella Zoster Immune Globulin (Human); Cangene; For the post-exposure prophylaxis of varicella zoster (chickenpox), Approved January 2013
10. Infections and Infectious Diseases
Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013
Sitavig (acyclovir) buccal tablets; BioAlliance Pharma; For the treatment of recurrent herpes labialis in adults, Approved April 2013
VariZIG, Varicella Zoster Immune Globulin (Human); Cangene; For the post-exposure prophylaxis of varicella zoster (chickenpox), Approved January 2013
11. Musculoskeletal
Actemra ((ocilizumab); Genentech; For the treatment of Polyarticular Juvenile Idiopathic Arthritis, Approved May 2013
Ilaris (canakinumab); Novartis; For the treatment of Systemic Juvenile Idiopathic Arthritis, Approved May 2013
Tecfidera (dimethyl fumarate); Biogen Idec; For the treatment of relapsing multiple sclerosis, Approved March 2013
12. Nephrology
Procysbi (cysteamine bitartrate); Raptor Pharmaceuticals; For the management of nephropathic cystinosis, Approved May 2013
Neurology
Nymalize (nimodipine); Arbor Pharmaceuticals; For the reduction of incidence and severity of ischemic deficits following subarachnoid hemorrhage, Approved May 2013
13. Nutrition and Weight Loss
Nesina (alogliptin); Takeda; For the treatment of type II diabetes mellitus, Approved January 2013
Obstetrics/Gynecology (Women’s Health)
Kadcyla (ado-trastuzumab emtansine); Genentech; For the treatment of HER2-positive metastatic breast cancer, Approved February 2013
Osphena (ospemifene); Shionogi; For the treatment of dyspareunia and vulvar and vaginal atrophy due to menopause, Approved March 2013
Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol); Teva Pharmaceutical; For the prevention of conception, Approved April 2013
14. Oncology
Kadcyla (ado-trastuzumab emtansine); Genentech; For the treatment of HER2-positive metastatic breast cancer, Approved February 2013
Pomalyst (pomalidomide); Celgene; For the treatment of relapsed and refractory multiple myeloma, Approved February 2013
Stivarga (regorafenib); Bayer; For the treatment of gastrointestinal stromal tumor, Approved February 2013
Xofigo (radium Ra 223 dichloride); Bayer Healthcare Pharmaceuticals; For the treatment of prostate cancer with bone metastases, Approved May 2013
15. Pediatrics/Neonatology
Actemra ((ocilizumab); Genentech; For the treatment of Polyarticular Juvenile Idiopathic Arthritis, Approved May 2013
Ilaris (canakinumab); Novartis; For the treatment of Systemic Juvenile Idiopathic Arthritis, Approved May 2013
Kineret, anakinra; Swedish Orphan Biovitrum; For the treatment of Cryopyrin-Associated Periodic Syndromes, Approved January 2013
Kynamro (mipomersen sodium); Genzyme; For the treatment of homozygous familial hypercholesterolemia, Approved January 2013
Ravicti (glycerol phenylbutyrate); Hyperion Therapeutics; For the treatment of pediatrics and adults with urea cycle disorders, Approved February 2013
16. Pharmacology/Toxicology
Kcentra (Prothrombin Complex Concentrate); CSL Behring; For the reversal of vitamin K antagonist therapy-induced coagulation factor deficiency, Approved May 2013
Pulmonary/Respiratory Diseases
Breo Ellipta (fluticasone furoate and vilanterol inhalation powder); GlaxoSmithKline; For the treatment of chronic obstructive pulmonary disease, Approved May 2013
17. Rheumatology
Actemra ((ocilizumab); Genentech; For the treatment of Polyarticular Juvenile Idiopathic Arthritis, Approved May 2013
Ilaris (canakinumab); Novartis; For the treatment of Systemic Juvenile Idiopathic Arthritis, Approved May 2013
Trauma (Emergency, Injury, Surgery)
Kcentra (Prothrombin Complex Concentrate); CSL Behring; For the reversal of vitamin K antagonist therapy-induced coagulation factor deficiency, Approved May 2013
18. Urology
Xofigo (radium Ra 223 dichloride); Bayer Healthcare Pharmaceuticals; For the treatment of prostate cancer with bone metastases, Approved May 2013
19. Vaccines
Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against influenza virus subtypes A and type B, Approved January 2013
VariZIG, Varicella Zoster Immune Globulin (Human); Cangene; For the post-exposure prophylaxis of varicella zoster (chickenpox), Approved January 2013
Source: www.centerwatch.com
No comments:
Post a Comment