Post-3:-INDIAN HEALTH MINISTRY's BAN
http://timesofindia.indiatimes.com/india/Govt-bans-350-drugs-including-Phensedyl-Corex/articleshow/51366873.cms
Govt bans 350 drugs, including Phensedyl, Corex
Sushmi Dey | TNN | Mar 12, 2016, 04.36 AM IST
The health ministry has banned around 350 fixed dose combination (FDC) drugs that were widely available in the market till now.
NEW
DELHI: In a significant move ensuring safety and efficacy of medicines,
the health ministry has banned around 350 fixed dose combination (FDC)
drugs that were widely available in the market till now. These medicines
include FDCs based on codine, used in popular cough syrups like
Phensedyl and Corex.
The government has decided to prohibit manufacturing and sale of these medicines because they were found to be "irrational" without any therapeutic efficacy and use. Also, in some cases, there were concerns about misuse of such medicines considered unsafe for mass consumption, official sources told TOI.
While the health ministry has already approved the ban order with immediate effect from Friday, the gazette notification is likely to be printed by Monday, a health ministry official said.
A fixed dose combination or FDC is one that contains two or more drugs combined in a fixed ratio of doses and available in a single dosage form.
The government has decided to prohibit manufacturing and sale of these medicines because they were found to be "irrational" without any therapeutic efficacy and use. Also, in some cases, there were concerns about misuse of such medicines considered unsafe for mass consumption, official sources told TOI.
While the health ministry has already approved the ban order with immediate effect from Friday, the gazette notification is likely to be printed by Monday, a health ministry official said.
A fixed dose combination or FDC is one that contains two or more drugs combined in a fixed ratio of doses and available in a single dosage form.
Health experts say many unapproved formulations and FDCs are sold in
India. Most of these medicines are in the analgesics, anti-depressant
and psychotic condition segment. Industry estimates suggest the move is
likely to impact pharmaceutical sales to the tune of around Rs 1,500
crore.
A study published in 2015 in journal PLOS Medicine pointed that over 12% of non-steroidal anti-inflammatory FDCs contain drugs that have either been withdrawn from the market or have had their use restricted.
A study published in 2015 in journal PLOS Medicine pointed that over 12% of non-steroidal anti-inflammatory FDCs contain drugs that have either been withdrawn from the market or have had their use restricted.
FDA Approved Drugs-2015
Source:http://www.johnsonlawgroup.com/pharmaceuticals-other-dangerous-pharmaceuticals/
The following database contains a listing of drugs approved by the Food and Drug Administration (FDA) for sale in the United States. Drug information typically includes the drug name, approval status, indication of use, and clinical trial results. Review descriptions for our medical therapeutic area list to help assist in your search.
Join our Drug Research Updates group on LinkedIn!
Find out more about the types of drugs included in this listing.
Cardiology/Vascular Diseases
Corlanor (ivabradine); Amgen; For the treatment of chronic heart failure, Approved April 2015
Entresto (sacubitril and valsartan); Novartis; For the treatment of chronic heart failure, Approved July 2015
Kengreal (cangrelor) ; The Medicines Company; For reducing periprocedural thrombotic events, Approved June 2015
Praluent (alirocumab); Sanofi Aventis; For the treatment of heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular disease, Approved July 2015
Prestalia (perindopril arginine and amlodipine besylate); Symplmed Pharmaceuticals; For the treatment of hypertension, Approved January 2015
Repatha (evolocumab) ; Amgen; For the treatment of high cholesterol, Approved August 2015
Savaysa (edoxaban); Daiichi Sankyo; For the treatment of deep vein thrombosis, pulmonary embolism and risk of stroke and embolism due to atrial fibrillation, Approved January 2015
Dermatology
Cosentyx (secukinumab); Novartis; For the treatment of plaque psoriasis, Approved January 2015Cotellic (cobimetinib) ; Genentech; For the treatment of BRAF V600E or V600K melanoma, Approved November 2015
Enstilar (calcipotriene and betamethasone dipropionate); LEO Pharmaceuticals; For the treatment of psoriasis, Approved October 2015
Imlygic (talimogene laherparepvec) ; Amgen; For the treatment of unresectable recurrent melanoma, Approved October 2015
Kybella (deoxycholic acid); Kythera Biopharma; For the treatment of submental fat, Approved April 2015
Odomzo (sonidegib); Novartis; For the treatment of locally advanced basal cell carcinoma, July 2015
Endocrinology
Addyi (flibanserin); Sprout Pharmaceuticals; For the treatment of premenopausal women with generalized hypoactive sexual desire disorder, Approved August 2015Natpara (parathyroid hormone) ; NPS Pharmaceuticals; For the control hypocalcemia in patients with hypoparathyroidism, Approved January 2015
Synjardy (empagliflozin and metformin hydrochloride) ; Boehringer Ingelheim; For the treatment of type II diabetes, Approved August 2015
Tresiba (insulin degludec injection); Novo Nordisk; For glycemic control in adults with diabetes mellitus, Approved September 2015
Family Medicine
Cosentyx (secukinumab); Novartis; For the treatment of plaque psoriasis, Approved January 2015Cresemba (isavuconazonium sulfate) ; Astellas; For the treatment of invasive aspergillosis and invasive mucormycosis, Approved March 2015
Enstilar (calcipotriene and betamethasone dipropionate); LEO Pharmaceuticals; For the treatment of psoriasis, Approved October 2015
Kybella (deoxycholic acid); Kythera Biopharma; For the treatment of submental fat, Approved April 2015
Savaysa (edoxaban); Daiichi Sankyo; For the treatment of deep vein thrombosis, pulmonary embolism and risk of stroke and embolism due to atrial fibrillation, Approved January 2015
Viberzi (eluxadoline); Actavis; For the treatment of irritable bowel syndrome with diarrhea, Approved May 2015
Xifaxan (rifaximin); Salix Pharmaceuticals; For the treatment of irritable bowel syndrome with diarrhea , Approved May 2015
Gastroenterology
Avycaz (ceftazidime-avibactam); Actavis; For the treatment of complicated intra-abdominal and urinary tract infections, Approved February 2015Cholbam (cholic acid); Asklepion Pharmaceuticals; For the treatment of bile acid synthesis and peroxisomal disorders, Approved March 2015
Lonsurf (trifluridine and tipiracil); Taiho Oncology; For the treatment of metastatic colorectal cancer , Approved September 2015
Onivyde (irinotecan liposome injection); Merrimack; For the treatment of metastatic pancreatic cancer following gemcitabine-based therapy, Approved October 2015
Varubi (rolapitant); Tesaro; For the prevention of delayed nausea and vomiting associated with chemotherapy, Approved September 2015
Viberzi (eluxadoline); Actavis; For the treatment of irritable bowel syndrome with diarrhea, Approved May 2015
Xifaxan (rifaximin); Salix Pharmaceuticals; For the treatment of irritable bowel syndrome with diarrhea , Approved May 2015
Genetic Disease
Strensiq (asfotase alfa); Alexion; For the treatment of hypophosphatasia, Approved October 2015
Xuriden (uridine triacetate); Wellstat Therapeutics; For the treatment of hereditary orotic aciduria, Approved September 2015
Hematology
Darzalex (daratumumab); Janssen Biotech; For the treatment of multiple myeloma, Approved November 2015Farydak (panobinostat); Novartis; For the treatment of multiple myeloma, Approved February 2015
Natpara (parathyroid hormone) ; NPS Pharmaceuticals; For the control hypocalcemia in patients with hypoparathyroidism, Approved January 2015
Nuwiq (recombinant Factor VIII); Octapharma; For the prophylaxis and treatment of hemophilia A, Approved September 2015
Praxbind (idarucizumab); Boehringer Ingelheim; For the reversal of the anticoagulant effects of dabigatran, Approved October 2015
Veltassa (patiromer); Relypsa; For the treatment of hyperkalemia, Approved October 2015
Hepatology (Liver, Pancreatic, Gall Bladder)
Cholbam (cholic acid); Asklepion Pharmaceuticals; For the treatment of bile acid synthesis and peroxisomal disorders, Approved March 2015Daklinza (daclatasvir) ; Bristol-Myers Squibb; For the treatment of chronic HCV genotype 3, Approved July 2015
Technivie, (ombitasvir, paritaprevir and ritonavir); Abbvie; For the treatment of chronic HCV genotype 4, Approved July 2015
Immunology
Cosentyx (secukinumab); Novartis; For the treatment of plaque psoriasis, Approved January 2015
Envarsus XR (tacrolimus extended-release); Veloxis; For the prophylaxis of organ rejection in kidney transplant patients , Approved July 2015
Evotaz (atazanavir and cobicistat) ; Bristol-Myers Squibb; For the treatment of HIV-1 infection, Approved January 2015
Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide); Gilead Sciences; For the treatment of HIV-1 infection, Approved November 2015
Prezcobix (darunavir and cobicistat); Janssen; For the treatment of HIV-1 infection, Approved January 2015
Infections and Infectious Diseases
Avycaz (ceftazidime-avibactam); Actavis; For the treatment of complicated intra-abdominal and urinary tract infections, Approved February 2015Bexsero (Meningococcal Group B Vaccine); Novartis; For the treatment of invasive meningococcal disease caused by serogroup B, Approved January 2015
Cresemba (isavuconazonium sulfate) ; Astellas; For the treatment of invasive aspergillosis and invasive mucormycosis, Approved March 2015
Daklinza (daclatasvir) ; Bristol-Myers Squibb; For the treatment of chronic HCV genotype 3, Approved July 2015
Evotaz (atazanavir and cobicistat) ; Bristol-Myers Squibb; For the treatment of HIV-1 infection, Approved January 2015
Fluad (trivalent influenza vaccine); Seqirus; For the prevention of influenza A and B, Approved November 2015
Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide); Gilead Sciences; For the treatment of HIV-1 infection, Approved November 2015
Prezcobix (darunavir and cobicistat); Janssen; For the treatment of HIV-1 infection, Approved January 2015
Technivie, (ombitasvir, paritaprevir and ritonavir); Abbvie; For the treatment of chronic HCV genotype 4, Approved July 2015
Musculoskeletal
Vivlodex (meloxicam) ; Iroko Pharmaceuticals; For the management of osteoarthritis pain, Approved October 2015Nephrology
Envarsus XR (tacrolimus extended-release); Veloxis; For the prophylaxis of organ rejection in kidney transplant patients , Approved July 2015Neurology
Aristada (aripiprazole lauroxil) extended-release injectable; Alkermes; For the treatment of schizophrenia, Approved October 2015Belbuca (buprenorphine) ; Endo Pharmaceuticals; For the management of severe pain, Approved October 2015
Duopa (carbidopa and levodopa) enteral suspension ; Abbvie; For the treatment of motor fluctuations in patients with advanced Parkinson's disease, Approved January 2015
Rytary (carbidopa and levodopa) extended-release capsules; Impax Labs; For the treatment of Parkinson's disease, Approved January 2015
Vivlodex (meloxicam) ; Iroko Pharmaceuticals; For the management of osteoarthritis pain, Approved October 2015
Vraylar (cariprazine); Allergan; For the treatment of schizophrenia and bipolar disorder, Approved September 2015
Obstetrics/Gynecology (Women’s Health)
Addyi (flibanserin); Sprout Pharmaceuticals; For the treatment of premenopausal women with generalized hypoactive sexual desire disorder, Approved August 2015
Ibrance (palbociclib); Pfizer; For the treatment of ER-positive, HER2-negative breast cancer, Approved February 2015
Oncology
Cotellic (cobimetinib) ; Genentech; For the treatment of BRAF V600E or V600K melanoma, Approved November 2015Darzalex (daratumumab); Janssen Biotech; For the treatment of multiple myeloma, Approved November 2015
Empliciti (elotuzumab); Bristol-Myers Squibb; For the treatment of patients with multiple myeloma who have received prior therapies, Approved November 2015
Farydak (panobinostat); Novartis; For the treatment of multiple myeloma, Approved February 2015
Ibrance (palbociclib); Pfizer; For the treatment of ER-positive, HER2-negative breast cancer, Approved February 2015
Imlygic (talimogene laherparepvec) ; Amgen; For the treatment of unresectable recurrent melanoma, Approved October 2015
Lenvima (lenvatinib); Eisai; For the treatment of thyroid cancer, Approved February 2015
Lonsurf (trifluridine and tipiracil); Taiho Oncology; For the treatment of metastatic colorectal cancer , Approved September 2015
Ninlaro (ixazomib); Millennium Pharmaceuticals; For the treatment of multiple myeloma, Approved November 2015
Odomzo (sonidegib); Novartis; For the treatment of locally advanced basal cell carcinoma, July 2015
Onivyde (irinotecan liposome injection); Merrimack; For the treatment of metastatic pancreatic cancer following gemcitabine-based therapy, Approved October 2015
Opdivo (nivolumab); Bristol-Myers Squibb; For the treatment of metastatic squamous non-small cell lung cancer, Approved March 2015
Portrazza (necitumumab) ; Eli Lilly; For the treatment of metastatic squamous non-small cell lung cancer, Approved November 2015
Tagrisso (osimertinib); AstraZeneca; For the treatment of EGFR T790M mutation positive non-small cell lung cancer , Approved November 2015
Unituxin (dinutuximab); United Therapeutics; For the treatment of pediatrics with high-risk neuroblastoma, Approved March 2015
Varubi (rolapitant); Tesaro; For the prevention of delayed nausea and vomiting associated with chemotherapy, Approved September 2015
Yondelis (trabectedin); Janssen; For the treatment of liposarcoma or leiomyosarcoma, Approved October 2015
Orthopedics/Orthopedic Surgery
Strensiq (asfotase alfa); Alexion; For the treatment of hypophosphatasia, Approved October 2015Pediatrics/Neonatology
Bexsero (Meningococcal Group B Vaccine); Novartis; For the treatment of invasive meningococcal disease caused by serogroup B, Approved January 2015Cholbam (cholic acid); Asklepion Pharmaceuticals; For the treatment of bile acid synthesis and peroxisomal disorders, Approved March 2015
Orkambi (lumacaftor and ivacaftor); Vertex Pharmaceuticals; For the treatment of cystic fibrosis, Approved July 2015
Strensiq (asfotase alfa); Alexion; For the treatment of hypophosphatasia, Approved October 2015
Unituxin (dinutuximab); United Therapeutics; For the treatment of pediatrics with high-risk neuroblastoma, Approved March 2015
Psychiatry/Psychology
Aristada (aripiprazole lauroxil) extended-release injectable; Alkermes; For the treatment of schizophrenia, Approved October 2015
Rexulti (brexpiprazole); Otsuka; For the treatment of depression and schizophrenia, Approved July 2015
Vraylar (cariprazine); Allergan; For the treatment of schizophrenia
SOURCE:-2015 FDA Approved Drugs//www.centerwatch.com/drug-information/fda-approved-drugs/
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