NEW DRUG APPROVALS BY FDA

Sirisha Pingali's picture
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The following drugs have recently been approved by the FDA.

Zenpep (pancrealipase) Capsules
Date of Approval: August 27, 2009
Treatment for: Pancreatic Exocrine Dysfunction

Sabril (vigabatrin) Tablets and Oral Solution
Date of Approval: August 21, 2009
Treatment for: Epilepsy, Seizures

Hiberix (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)) Solution for Intramuscular Injection
Date of Approval: August 19, 2009
Treatment for: Haemophilus influenzae Prophylaxis

Saphris (asenapine) Sublingual Tablets
Date of Approval: August 13, 2009
Treatment for: Schizophrenia, Bipolar Disorder

Embeda (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules
Date of Approval: August 13, 2009
Treatment for: Pain

Livalo (pitavastatin) Tablets
Date of Approval: August 3, 2009
Treatment for: High Cholesterol

Lipsovir (acyclovir and hydrocortisone) Topical Cream
Date of Approval: July 31, 2009
Treatment for: Herpes Simplex Labialis

References:
News Letter Volume 60 from www.drugs.com

Santosh Kumar. JH's picture

Great work done

4

Dear Sirisha,
Good collection
Can I know who is the innovator of pitavastatin ?

Regards,
Santosh Kumar

http://www.pharmainfo.net/santosh-kumar-jh
ATHARVANA

Sirisha Pingali's picture

Pitavastatin (previously

dear santosh..
thank you for your valuable comment...
Pitavastatin (previously known as itavastatin, itabavastin, nisvastatin) was discovered in Japan by Nissan Chemical Industries, Ltd. and developed further by Kowa Pharmaceuticals, Tokyo.

Santosh Kumar. JH's picture

Thank you so much

Its been pleasure hearing from you...
How does Pitavastatin differ from Atorvastatin ?
Which is the best one ?

Regards,
Santosh Kumar

http://www.pharmainfo.net/santosh-kumar-jh
ATHARVANA

Sirisha Pingali's picture

dear santosh.. definitely

dear santosh..
definitely atorvastatin is one of the best drugs among all the statins. It is mainly prescribed because of its long duration of action. Its a very common mediacation available in the brandname of ATOCOR in various doses

Supriya vavilapalli's picture

good collection

5

keep it up

Supriya vavilapalli

THE COGNITIVE MOLECULES

http://www.pharmainfo.net/supriya-vavilapalli

Sirisha Pingali's picture

dear supriya.. thank you for

dear supriya..
thank you for your valuable comment..

Shiv Majumdar's picture

Good efforts

5

Dear Sirisha,

Good efforts & compilation.

Keep updating us by providing such knowledge.

Regards
shiv
Team "INFINITY"

Sirisha Pingali's picture

sir.. thank you for your

sir..
thank you for your valuable comment..

ks kumar upadhyayula's picture

Good Information

3

Dear Sirisha,

Very nice blog on updated information and can you specify the priority in approving the drugs?I mean by their class or their economy or its demand and uses etc...

Regards,
K.S.Kumar Upadhyayula
"Pharmers"

Sirisha Pingali's picture

dear suresh.. thank you for

dear suresh..
thank you for your valuable comment..
Safety, Efficiency are the two factors considered by the individual whenever a new drug is released into market..But is safety is the only criteria?? No..Check the following link to grab the point
http://www.center4research.org/news/fda-adv-committee.html

ks kumar upadhyayula's picture

Thank you

Dear Sirisha,

Thank you very much

Amol S. Malpani's picture

august seems to be a good month

4

Dear Sirisha,
good one.
Regards,
Amol Malpani

Sirisha Pingali's picture

sir.. thank you for your

sir..
thank you for your valuable comment..

Udayasree Datla's picture

Good Information

3

Dear Sirisha,

Can you please tell to what category do all these drugs belong?

Sirisha Pingali's picture

dear udayasree,,thank you

dear udayasree,,
thank you for your valuable comment..
the name in the brackets indicates the class to which the drug belong..
for eg:Livalo (pitavastatin) belongs to STATINS

Zarrin Faria's picture

Dear Srisha good

5

Dear Srisha good information....
Is the number of drug approvals this year greater or less than next year...
Regards,
Faria Zarrin
Team: BLOGBUSTERS

Sirisha Pingali's picture

dear faria.. thank you for

dear faria..
thank you for your valuable comment..Please check the following link to know the approvals by FDA in 2008.
http://www.emaxhealth.com/1024/94/27915/fda-approved-drugs-during-2008.html