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FDA Approved and Recalled drugs from May 2011 to Dec 2011

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FDA-Approved Drugs in 2011

Cardiology/Vascular Diseases

Brilinta (ticagrelor); AstraZeneca; For the reduction of thrombotic events in patients with acute coronary syndrome, Approved July 2011

Edarbyclor (azilsartanmedoxomilandchlorthalidone); Takeda Pharmaceutical; For the treatment of hypertension, Approved December of 2011

Xarelto (rivaroxaban); Janssen Pharmaceuticals; For the reduction in the risk of stroke and systemic embolism resulting from atrial fibrillation, Approved November 2011

Dermatology/Plastic Surgery

Firazyr (icatibant); Shire; For the treatment of acute attacks of hereditary angioedema, Approved August of 2011

laViv (azficel–T); Fibrocell Science; For the improvement of nasolabial fold wrinkles in adults, Approved June 2011

Endocrinology

Tradjenta (linagliptin); Boehringer Ingelheim; For the treatment of type II diabetes, Approved May 2011

Gastroenterology

Dificid (fidaxomicin); Optimer Pharmaceuticals; For the treatment of Clostridium difficile-associated diarrhea, Approved May 2011

Incivek (telaprevir); Vertex; For the treatment of genotype 1 chronic hepatitis C, Approved May 2011

Victrelis (boceprevir); Merck; For the treatment of chronic hepatitis C genotype 1, Approved May 2011

 

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Drugs banned in developed world sold in India: Parliamentary Panel -List of Drugs Banned in India PDF

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The Parliamentary Standing Committee on Health and Family Welfare also pointed to serious lapses and irregularities on the approvals of new drugs and pointed out that 33 such drugs were approved without conducting clinical trials on Indian patients.

The Committee said scrutiny of 42 drugs picked up randomly involving grant of drug approvals in utter disregard of regulatory procedures and violation of rules and pointed out to files of approval of three controversial drugs (pefloxacin, lomefloxacin and sparfloxacin) found missing and untraceable.

These drugs were either never marketed or withdrawn in the US, Canada, Britain, Australia and other countries.

Citing the example of Deanxit, the Panel pointed out that the drug continued to be prohibited for sale and use in Denmark, the country of its origin, and thus permission to import and market it in India was given unlawfully.The panel cited another example of Letrozole by Novartis, used as an anti-cancer drugs used only in post-menopausal women, is used only in India where it is permitted for use in female infertility.

329 Banned Drugs List in India – PDF Full Download – 2018 – Latest News

List of Drugs Banned in India

A. Single drug preparations (or combinations of)

1. Amidopyrine
2. Phenacetin
3. Nialamide
4. Methaqualone
5. Methapyriline (and its salts)
6. Practolol
7. Penicillin skin/eye ointment
8. Tetracycline/Oxytetracyline/Demeclocycline liquid oral preparations.
9. Chloral hydrate
10. Dover’s powder and Dover’s powder tablets I.P.
11. Chloroform exceeding 0.5% w/w or v/v in pharmaceutical preparations.
12. Mepacrine HCl (Quinacrine and its salts) in any dosage form for use for female sterilization
or contraception.
13. Fenfluramine
14. Dexfenfluramine
15. Terfenadine
16. Astemizole
17. Phenformin
18. Rofecoxib
19. Valdecoxib
20. Rosiglitazone
21. Nimesulide Formulatios In Children Below The Age Of 12 years
22. Cisapride
23. Rimonabant
24. Phenyl Propanolamine
25. Human Placenta Extract in topical application for wound healing and injection for pelvic
inflammatory diseases.
26. Sibutramine
27. R-Sibutramine
28. Gatifloxacin
29. Tegaserod

B. Fixed dose combination with any other drug

1. Corticosteroids with any other drug for internal use.
2. Chloramphenicol with any other drug for internal use.
3. Sodium bromide/chloral hydrate with other drugs.
4. Ergot with any drug except preparations containing ergotamine, caffeine, analgesics,
antihistamines for treatment of migraine.
5. Anabolic steroids with other drugs.
6. Metoclopramide with other drugs (except with aspirin/paracetamol).
7. Pectin and/or kaolin with any drug which is systematically absorbed from g.i. tract, except
for combination of pectin and/or kaolin with drugs not systematically absorbed.
8. Hydroxyquinolines with any other drug except in preparations for external use.
9. Oxyphenbutazone or phenylbutazone with any other drug.
10. Dextropropoxyphene with any other drug except antispasmodics and/or NSAIDs.
11. Analgin (metamizol) with any other drug.

list of drugs banned in India PDF – 2018

C. Fixed dose drug combinations of

1. Penicillins with Sulfonamides.
2. Tetracyclines with Vitamin C
3. Antitubercular drugs with Vitamins (except Isoniazid with Pyridoxine HCl).
4. Vitamins with Analgesics/Antiinflammatory drugs.
5. Vitamins with Tranquillisers.
6. Atropine and Analgesic-antipyretics.
7. Yohimbine and Strychnine with Testosterone and Vitamins.
8. Strychnine and Caffeine in tonics.
9. Iron with Strychnine, Arsenic and Yohimbine.
10. Antihistaminics with Antidiarrhoeals.
11. More than one Antihistamine in the same preparation.
12. Sedatives/Hypnotics/Anxiolytics with Analgesic-antipyretics.
13. H2 receptor antagonists with Antacids (except those combinations approved by Drugs
Controller, India).
14. Anthelmintics (except Piperazine) with a Cathartic/Purgative.
15. Salbutamol (or any other bronchodilator) with centrally acting Antitussive and/or an
Antihistamine.
16. Centrally acting Antitussives with Antihistamines having atropine like activity in
expectorants.
17. Centrally acting Antitussive and/or Antihistamine in preparations for cough associated with
asthma.
18. Laxative and/or antispasmodic drugs in enzyme preparations.
19. Glycerophosphates and/or other phosphates and/or CNS stimulant in liquid oral tonics.
20. Estrogen and Progestin (other than oral contraceptives) containing per tablet Estrogen more
than 50 ug ethinylestradiol (or equivalent) and progestin more than 3 mg of norethisterone
acetate (or equivalent) and, all fixed dose combination injectable preparations containing
synthetic estrogen and progesterone.
21. Ethambutol with Isoniazid, except in the following daily doses:
Isoniazid 200 mg + Ethambutol 600 mg or
Isoniaizd 300 mg + Ethambutol 800 mg
22. Pyrazinamide with other antitubercular drugs, except that which provide the following daily
doses.
Rifampicin 450 to 600 mg
Isoniazid 300 to 400 mg
Pyrazinamide 1000 to 1500 mg
23. Essential oils with Alcohol having percentage higher than 20% proof (except preparations
given in the I.P.).
24. Liquid oral tonic preparations containing alcohol more than 20% proof.
25. Streptomycin with penicillin in parenteral preparation.
26. Antidiarrhoeals containing adsorbants like kaolin, pectin, attapulgite, activated charcoal etc.
27. Antidiarrhoeals containing phthalylsulfathiazole, succinyl sulfathiazole, sulfaguanidine,
neomycin, streptomycin, dihydrostreptomycin.
28. Antidiarrhoeal formulations for pediatric use containing diphenoxylate, loperamide, atropine,
hyoscyamine, halogenated hydroxyquionolines.
29. Antidiarrhoeals with electrolytes.
30. Fixed dose combinations of haemoglobin in any form.
31. Pancreatine or pancrelipase containing amylase, protease and lipase with any other enzyme.
32. Oral rehydration salts other than those conforming to the following parameters:
a) Oral rehydration salts on reconstitution to one litre shall contain: sodium-50 to 90 mM;
total osmolarity-240 to 290 mOsm; dextrose: sodium molar ratio-not less than 1:1 and not
more than 3:1.
b) Cereal based ORS on reconstitution to one litre shall contain: total osmolarity not more
than 2900 mOsm. Precooked rice equivalent to not less than 50 g and not more than 80 g
as total replacement of dextrose.
c) ORS may contain amino acids in addition to ORS conforming to the parameters
specified above and labeled with the indication for “Adult Choleratic Diarrhoea” only.
d) ORS shall not contain mono or polysaccharides or saccharin sweetening agent.
33. A drug, standards of which are prescribed in the 2nd schedule to Drugs and Cosmetics Act
with an Ayurvedic Siddha or Unani drug.
34. Vitamin B1, Vit B6 and Vit B12 for human use.
35. Diazepam with diphenhydramine HCl.
36. Nitrofurantoin with Trimethoprim.
37. Phenobarbitone with any antiasthmatic drug, or with hyoscine and/or Hyoscyamine, or
ergotamine and/or belladonna.
38. Haloperidol with any anticholinergic agent including propantheline Br.
39. Nalidixic acid with any antiamoebic including metronidazole.
40. Loperamide with furazolidone.
41. Cyproheptadine with lysine or peptone.
42. Diazepam and Diphenhyhydramine Hydrochloride.

Low oxygen levels drive cancer growth

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f hypoxia, or low oxygen levels in cells, is proven to be a key driver of certain types of cancer, treatment plans for curing the malignant growth can change in significant ways, said Ying Xu, professor of bioinformatics and computational biology at Georgia University’s Franklin College of Arts and Sciences.

The research team analysed samples of messenger RNA data, also called transcriptomic data, from seven different cancer types in a publicly available database.

They found that long-term lack of oxygen in cells may be a key driver of cancer growth, the Journal of Molecular Cell Biology reports.

Previous studies had linked low oxygen levels in cells as a contributing factor in cancer development, but not as the driving force for cancer growth.

High cancer rates worldwide cannot be explained by chance genetic mutations alone, Xu said, according to a Georgia statement.

He added that bioinformatics, which melds biology and computational science, has allowed researchers to see cancer in a new light.

“Cancer drugs try to get to the root, at the molecular level, of a particular mutation, but the cancer often bypasses it,” Xu said.

“So we think that possibly, genetic mutations may not be the main driver of cancer.”

The researchers analysed data downloaded from the Stanford Microarray database via a software programme to detect abnormal gene expression patterns in seven cancers: breast, kidney, liver, lung, ovary, pancreatic and stomach.

Xu relied on the gene HIF1A as a biomarker of the amount of molecular oxygen in a cell. All seven cancers showed increasing amounts of HIF1A, indicating decreasing oxygen levels in the cancer cells.

Low oxygen levels in a cell interrupt the activity of oxidative phosphorylation, a term for the highly efficient way that cells normally use to convert food to energy.

Low oxygen levels engender the process of creating new blood vessels. They provide fresh oxygen, thus improving oxygen levels in the cell and tumour and slowing the cancer growth – but only temporarily.

“When a cancer cell gets more food, it grows; this makes the tumour biomass bigger and even more hypoxic. In turn, the energy-conversion efficiency goes further down, making the cells even hungrier and triggering the cells to get more food from blood circulation, creating a vicious cycle. This could be a key driver of cancer,” Xu said.

FDA issues final rule on sterility testing of biological products

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The U.S. Food and Drug Administration issued its final rule on sterility testing, amending the requirements for most licensed biological products. The action follows a retrospective review of agency regulations to promote improvement and innovation and is in response to Executive Order 13563 that is designed to improve regulation and regulatory review.
The FDA recognizes the role innovation plays in bringing safe and effective products to market in a timely and cost-efficient manner. This action reflects the agency’s efforts to review and, as necessary, update biologics regulations, to keep pace with technological developments and to boost regulatory science.
The amendments to the sterility testing rule will provide manufacturers of biological products the flexibility, as appropriate, to keep pace with technological and scientific advances.

FDA issued a final rule on sterility testing on May 3, 2012, that amends the requirements for most licensed biological products and aims to provide manufacturers with the flexibility, as appropriate, to keep pace with technological and scientific advances. The rule is in response to President Obama’s Executive Order 13563 which called for improving regulation and regulatory review.

Specifically, the rule revises sterility requirements under Title 21 of the Code of Federal Regulations (CFR), subchapter F, parts 600 through 680 as follows:

  1. “Eliminates specified sterility test methods, culture media formulae (or formulation), and culture media test requirements
  2. Eliminates specified membrane filtration procedure requirements for certain products
  3. Eliminates specified sterility test requirements for most bulk material
  4. Modifies the repeat sterility test requirements, so that repeat tests will occur only once for each lot
  5. Replaces the storage and maintenance requirements for cultures of test organisms used to determine the “growth-promoting qualities” of culture media with validation requirements specifying that any sterility test used is able to consistently detect the presence of viable contaminating microorganisms, and with verification of “growth-promoting properties” or microorganism-detection capabilities of test and test components
  6. Replaces the sample size or amount requirement with a requirement that the sample be appropriate to the material being tested
  7. Replaces the Interpretation of test results section under § 610.12(c) with a requirement that manufacturers establish, implement, and follow written procedures for sterility testing that describe, at a minimum, the test method used, the method of sampling, and the written specifications for acceptance or rejection of each lot
  8. Simplifies and clarifies the Exceptions section under § 610.12(h)
  9. Identifies the Director of CDER as one of the two Center directors authorized to grant an exemption under the exception provision at § 610.12(h)(2). In the proposed rule, the Center for Devices and Radiological Health was erroneously identified in this exception, instead of the Center for Drug Evaluation and Research
  10. Revises the definition of the term “sterility” under § 600.3(q).
  11. Eliminates certain exceptions for allergenic products related to sterility testing under § 680.3(c).”

Companies will not have long to implement the changes as the rule takes effect June 4, 2012. The proposed rule received several comments from industry and the final rule includes the agency’s response to those recommendations. Overall, FDA “recognizes the role innovation plays in bringing safe and effective products to market in a timely and cost-efficient manner,” according to an FDA announcement of the rule. “This action reflects the agency’s efforts to review and, as necessary, update biologics regulations, to keep pace with technological developments and to boost regulatory science.”

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Source:

http://www.fda.gov/

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Cancer drugs to cost less, Cipla slashes prices !!!

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Cipla, has announced a massive reduction of up to 76 per cent in its cancer drug prices after the Indian government recently lifted a patent license.

Following the move,

  • The price of Cipla’s generic kidney cancer drug, Sorafenib, will be available at Rs 6,840 a month from the earlier Rs 27,950.
  • The lung cancer drug Gestinib price has been cut down by 60 per cent to just over Rs 4000, instead of earlier Rs 10,200.
  • Temozolamide, a very effective brain tumour treatment drug has come down to Rs 5000 from the original Rs 20,250.