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New Medicines

New drugs recently approved by the FDA.

New transdermal form of Sufentanil in the works

August 15, 2009 by Lung Dr.
Posted in

Transdur, is a transdermal sufentanil patch under development, which is expected to pass Phase III clinical trials. 

As opposed to the more common Duragesic(R) patches with fentanyl, which last from 2 to 3 days, Transdur purportedly lasts a whole seven days.  They also will be available in very small, skin colored patches that are up to 1/4 as small as Duragesic(R) patches.

Sufentanil, a potent, synthetic opioid analgesic, is 5 to 10 times more potent than its analog, fentanyl. 

 

www.durect.com/wt/durect/page_name/trans_sufentanil

 

If approved, they will likely be available in 4 strengths, 25, 50, 75, and 100 mcg/hr.  These are the same strengths that Duragesic(R) patches are available, but keep in mind that sulfentanil is 5 to 10 times more potent than Fentanyl!

 

Would be great for some opioid tolerant pain suffers out there. We'll have to wait and see if it gets approval.

 

There is a new form of Fentanyl available for breakthrough pain (BTP).

August 2, 2009 by allgood
Posted in

"Onsolis contains fentanyl in a small film (about the size of a dime or nickel) that sticks to the inside of your cheek."

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm172039.htm

 

The "film" sounds similar to those breath mint, film Listerines (Breath Strips).

 

Only available to cancer patients.

 

 

edit/g

Generic Prevacid in Canada

July 26, 2009 by Sarcophagus
Posted in

I was just informed by my pharmacy that there is a generic out now for the stomach/acid medicine Prevacid.

Rx'd Nucynta along with Methadone

July 24, 2009 by MattMason
Posted in

Rx'd Nucynta along with Methadone

I am a 48 yr old male, with ideopathic osteoporosis, diagnosed when I was in early thirties. I have 6 thoracic compression fractures.

I have been on 40 mgs of methadone for 14 years, started seeing a new pain mgt. Doc 1.5 years ago,  that has kicked it up to 50 Mg's and added 30 mg's of oxycodone for breahthrough.

Today he gave me a script for Nucynta 50mg's 5 dailey.In place of the oxy. As I  Cannot seem to find much info on that new medicine.Anyone habe any ideas how it will act with the methadone?

Is it supposed to be non addictive? or does it act as a regular opiod with euphoric sensation..

 

Any input would really help.

Thanks

First-Time Generics - June 2009

July 24, 2009 by TP Admin
Posted in

First-Time Generic Approvals - June 2009

Tablets/Capsules Only
Generic
Drug Name		 Generic
Manufacturer		 Referenced
Brand Name		 Approval
Date		 Pill
Identification
OMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, (OTC) 20 MG (BASE) DR. REDDY'S PRILOSEC OTC DELAYED-RELEASE CAPSULES 06-05-09
LEVONORGESTREL TABLETS (Rx) 0.75 MG WATSON PLAN B (LEVONORGESTREL) TABLETS, 0.75 MG 06-24-09 Round peach Watson 475
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS USP, 0.180 MG/0.025 MG; 0.215 MG/0.025 MG AND 0.250 MG/0.025 MG (28-DAY REGIMEN) BARR LABS (Teva) ORTHO TRI CYCLIN LO 06-29-09

Sources: US Food and Drug Administration and manufacturers' websites

First-Time Generics - May 2009

July 24, 2009 by TP Admin
Posted in

The US Food and Drug Administration approved no first-time generic tablets or capsules during the month of May 2009. The only first-time generic approval was Kenalog-10 injectable suspension.

APLENZIN a new hydrobromide salt of Bupropion XL

June 30, 2009 by tabletpharmer
Posted in

Aplenzin became available in April, 2009. I seem to be one of the few people who take it, so I decided to capture a photo and post it in the contrib section. Here's what it looks like:

Aplenzin

 

 

 

First-Time Generics - April 2009

May 15, 2009 by TP Admin
Posted in

First-Time Generic Approvals - April 2009

Tablets/Capsules Only
Generic
Drug Name		 Generic
Manufacturer		 Referenced
Brand Name		 Approval
Date		 Pill
Identification
TOPIRAMATE CAPSULES (SPRINKLE), 15 MG AND 25 MG COBALT TOPAMAX SPRINKLE CAPSULES 04-15-09 15 mg - white TI 15; 25 mg - white TI 25
TOPIRAMATE CAPSULES (SPRINKLE), 15 MG AND 25 MG BARR LABS (Teva) TOPAMAX SPRINKLE CAPSULES 04-15-09 15 mg - white 93 7335; 25 mg - white 93 7336
RISPERIDONE ORALLY DISINTEGRATING TABLETS, 0.25 MG, 0.5 MG, 2 MG, 3 MG AND 4 MG KALI LABS RISPERDAL M-TAB (ORALLY DISINTEGRATING TABLET) 04-30-09

Sources: US Food and Drug Administration and manufacturers' websites

First-Time Generics - March 2009

April 12, 2009 by TP Admin
Posted in

First-Time Generic Approvals - March 2009

Tablets/Capsules Only
Generic
Drug Name		 Generic
Manufacturer		 Referenced
Brand Name		 Approval
Date		 Pill
Identification
LIOTHYRONINE SODIUM TABLETS, USP 5 MCG, 25 MCG, AND 50 MCG COASTAL PHARMA CYTOMEL TABLETS 03-20-09
IBUPROFEN CAPSULES, 200 MG (LIQUID FILLED CAPSULE) (OTC) BANNER ADVIL LIQUI-GELS CAPSULES 03-24-09
TOPIRAMATE TABLETS, 25 MG, 50 MG, 100 MG AND 200 MG TEVA TOPAMAX TABLETS 03-27-09 25 mg - oblong white 93 155; 50 mg - oblong yellow 93 7540; 100 mg - oblong yellow 93 7219; 200 mg - oblong salmon 93 7220
TOPIRAMATE TABLETS, 25 MG, 50 MG, 100 MG AND 200 MG ZYDUS TOPAMAX TABLETS 03-27-09 25 mg - round white ZD 16; 50 mg - round white ZD 15; 100 mg - round white ZD 14; 200 mg - round white ZD 13
TOPIRAMATE TABLETS, 25 MG, 50 MG, 100 MG AND 200 MG AUROBINDO TOPAMAX TABLETS 03-27-09 25 mg - round white E 22; 50 mg - round yellow E 33; 100 mg - round yellow E 23; 200 mg - round pink E 24
TOPIRAMATE TABLETS, 25 MG, 50 MG, AND 100 MG UNICHEM TOPAMAX TABLETS 03-27-09
TOPIRAMATE TABLETS, 25 MG, 50 MG, 100 MG AND 200 MG INVAGEN TOPAMAX TABLETS 03-27-09 25 mg - round white IG 278; 50 mg - round yellow IG 279; 100 mg - round yellow IG 280; 200 mg - round pink IG 281
TOPIRAMATE TABLETS, 25 MG, 50 MG, 100 MG AND 200 MG SUN (Caraco) TOPAMAX TABLETS 03-27-09 25 mg - round white S 707; 50 mg - round yellow S 710; 100 mg - round yellow S 711; 200 mg - round brown S 712
TOPIRAMATE TABLETS, 25 MG, 100 MG AND 200 MG BARR TOPAMAX TABLETS 03-27-09
TOPIRAMATE TABLETS, 25 MG, 50 MG, 100 MG AND 200 MG ROXANE TOPAMAX TABLETS 03-27-09
TOPIRAMATE TABLETS, 25 MG, 50 MG, 100 MG AND 200 MG GLENMARK TOPAMAX TABLETS 03-27-09
TOPIRAMATE TABLETS, 25 MG, 50 MG, 100 MG AND 200 MG APOTEX TOPAMAX TABLETS 03-27-09 25 mg - round white APO TP 25; 50 mg - round yellow APO TP 50; 100 mg - round yellow APO TP 100; 200 mg - round reddish brown APO TP 200
TOPIRAMATE TABLETS, 25 MG, 50 MG, 100 MG AND 200 MG MYLAN TOPAMAX TABLETS 03-27-09 25 mg - round white M T11; 50 mg - round white M T12; 100 mg - round white M T13; 200 mg - oval white M T15
TOPIRAMATE TABLETS, 25 MG, 50 MG, 100 MG AND 200 MG CIPLA TOPAMAX TABLETS 03-27-09
TOPIRAMATE TABLETS, 25 MG, 50 MG, 100 MG AND 200 MG PAR TOPAMAX TABLETS 03-27-09
TOPIRAMATE TABLETS, 25 MG, 100 MG AND 200 MG RANBAXY TOPAMAX TABLETS 03-27-09 25 mg - round white RX 778; 100 mg - round yellow RX 779; 200 mg - round reddish brown RX 780
TOPIRAMATE TABLETS, 25 MG, 50 MG, 100 MG AND 200 MG TORRENT TOPAMAX TABLETS 03-27-09 25 mg - round white 1031 25; 50 mg - round yellow 1032 50; 100 mg - round yellow 1033 100; 200 mg - round peach 1034 200
DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS, 3 MG/0.02 MG (28-DAY REGIMEN) BARR YAZ TABLETS 03-30-09
CARBAMAZEPINE EXTENDED-RELEASE TABLETS USP, 100 MG, 200 MG AND 400 MG TARO TEGRETOL-XR TABLETS 03-31-09

Sources: US Food and Drug Administration and manufacturers' websites

Pill imprints updated 05-10-09

First-Time Generics - February 2009

March 28, 2009 by TP Admin
Posted in

First-Time Generic Approvals - February 2009

Tablets/Capsules Only
Generic
Drug Name		 Generic
Manufacturer		 Referenced
Brand Name		 Approval
Date		 Pill
Identification
MINOCYCLINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 45 MG, 90 MG AND 135 MG IMPAX LABS SOLODYN TABLETS 02-03-09
SUMATRIPTAN SUCCINATE TABLETS, 25 MG, 50 MG AND 100 MG TEVA IMITREX TABLETS 02-09-09 25 mg - oblong white 93 222; 50 mg - oblong white 93 223; 100 mg - oblong pink 93 224
SUMATRIPTAN SUCCINATE TABLETS, 100 MG RANBAXY IMITREX TABLETS 02-09-09 100 mg - oblong white RB 97
RISPERIDONE ORALLY DISINTEGRATING TABLETS, 0.5 MG AND 2 MG DR. REDDY'S RISPERDAL M-TAB (ORALLY DISINTEGRATING TABLET) 02-24-09

Sources: US Food and Drug Administration and manufacturers' websites

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