FDA Approved and Recalled drugs from May 2011 to Dec 2011

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 (azficelT); 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

 

for more click here

NIPER JEE 2012 Important dates, Admission, Application

Important Dates for Admission

Date of commencement of online Registration———1st June 2012

Last date for online Rregistration
13th June 2012

Last date of receipt of filled registration slips
20th June 2012

Date of issue of admit card by e-mail/downloadable from website
27th June 2012

NIPER Joint Entrance Examination (10:00 am. to 12.00 noon)
1st July 2012

Declaration of result of written test
6th July 2012 (Website-www.niper.gov.in/niperjee2012.html)
Group discussion and Interview for M.B.A (Pharm.)
11th-12th July, 2012

Declaration of the list of selected and waitlisted candidates of M.B.A. (Pharm.)
13th July, 2012

Admission of selected and waitlisted candidates of M.B.A (Pharm.)
13th July, 2012

NIPER Joint Counselling for admission to Masters Programme
17th-19th July, 2012

Orientation
27th July, 2012

Commencement of classes
30th July, 2012

 

NIPER jee important dates

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

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.

NIPER booster 3

Niper Booster 3

1.  The Director General of World Health Organization is

a. Dr. Ala Alawan

b. Dr. Mirta Roses

c. Dr. Margaret Chan

d. Dr. Shin Young-Soo

 

2.  The New Molecular Entity approved by the FDA for treatment of head lice infections

a. ARGATROBAN

b. SPINOSAD

c. VILAZODONE HYDROCHLORIDE

d. ROFLUMILAST

 

3.  The total number of monographs in the latest edition of Indian Pharmacopoeia

a. 1846

b.1918

c.2340

d.1790

 

4. How many pints make a gallon?

a. 16

b.20

c.6

d.8

 

5. Inulin is a

a. Lignan

b. Fructan

c. Flavonoid

d.  Resin

 

6. Borax reaction and Bromine test are

a. Specific tests for Anthraquinone glycosides

b. General tests for Flavonoids

c. Specific test for Tannins

d. General tests for Aloes

7. Identify the Motilin agonist

a. Paclitaxel

b. Ceftrioxime

c. Rifampicin

d. Erythromycin

 

ANSWERS:

1.c. Dr. Margaret Chan

2.b. SPINOSAD

3.b.1918

4.d.8

5.b. Fructan ( Refer Trease and Evans page 207)

6.d. General tests for Aloes ( Refer Trease and Evans Page 247)

7.d. Erythromycin ( Refer Goodman and Gilman page 636)

 

NIPER booster 1

General Knowledge –

 

1. The Drug of Novartis that is challenged in the Indian courts for the validity of Patent?

2. Fundamental rights of an Indian Citizen are ____ in number.

3. Lipitor is the brand name of which drug?

4.Pharmaceutical Patents in India are currently granted as —————— patents (product/process)

5. The Director General of World Health Organization is

a. Dr. Ala Alawan
b. Dr. Mirta Roses
c. Dr. Margaret Chan
d. Dr. Shin Young-Soo

NOTE: This is a trial pack with only 5 questions and explanations. You can expect more questions every day. We have a lot of mnemonics that will help you for your NIPER preparation. You can also send your questions by using the contact form above. From tomorrow onwards we will provide the NIPER booster packs only to registered users, so please register by clicking  here 

Answers:

1. Gleevec, Imitinab mesylate, is used in treating chronic myelogenous leukemia (CML), gastrointestinal stromal tumors (GISTs) and some other diseases. It was challenged in the MADRAS HIGH COURT on the grounds lacking NOVELTY as per Section 3(d) of Indian Patent Act. Gleevec was said to lack novelty because it was just a different salt form with no improved therapeutic efficacy of an already existing patent. (a term called EVERGREENING of patents)

http://en.wikipedia.org/wiki/Imatinib

 

2.  The six fundamental rights recognised by the constitution are:

1) Right to equality, including equality before law, prohibition of discrimination on grounds of religion, race, caste, sex or place of birth, and equality of opportunity in matters of employment, abolition of untouchability and abolition of titles.

2) Right to freedom which includes speech and expression, assembly, association or union or cooperatives, movement, residence, and right to practice any profession or occupation (some of these rights are subject to security of the State, friendly relations with foreign countries, public order, decency or morality), right to life and liberty, right to education, protection in respect to conviction in offences and protection against arrest and detention in certain cases.

3) Right against exploitation, prohibiting all forms of forced labour, child labour and traffic in human beings;

4) Right to freedom of religion, including freedom of conscience and free profession, practice, and propagation of religion, freedom to manage religious affairs, freedom from certain taxes and freedom from religious instructions in certain educational institutes.

5) Cultural and Educational rights preserving Right of any section of citizens to conserve their culture, language or script, and right of minorities to establish and administer educational institutions of their choice; and

6) Right to constitutional remedies for enforcement of Fundamental Rights.

http://en.wikipedia.org/wiki/Fundamental_Rights_in_India#Right_To_Education

 

3. Lipitor, is trade name of the calcium salt of  Atorvastatin  marketed by Pfizer . It is a member of the drug class known as statins, used for lowering blood cholesterol. Generic atorvastatin, manufactured by generic drugmakers Watson Pharmaceuticals and India’sRanbaxy Laboratories, began being available in the United States on November 30, 2011 and are going to be cheaper than Lipitor.

http://en.wikipedia.org/wiki/Atorvastatin

4. Pharmaceutical patents in India are granted as PRODUCT patents as per Indian Patent Law of 2005. earlier they were granted process patents.However Until 2005, Indian law recognized only process patents for making pharmaceutical products—and not the actual products.

India patent denied drugs

http://online.wsj.com/article/SB10001424052748703455804575057621354459804.html

 

5. Dr. Margaret Chan