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New Medicines

New drugs recently approved by the FDA.

First-Time Generics - September 2008

November 8, 2008 by TP Admin
Posted in

First-Time Generic Approvals - September 2008

Tablets/Capsules Only
Generic
Drug Name		 Generic
Manufacturer		 Referenced
Brand Name		 Approval
Date		 Pill
Identification
GALANTAMINE HYDROBROMIDE ER CAPSULES 8 MG, 16 MG, AND 24 MG BARR LABS RAZADYNE ER 09-15-08 8 mg - light beige capsule Barr 8 mg 1020; 16 mg - pink capsule Barr 16 mg 1021; 24 mg - tan capsule Barr 24 mg 1022

Sources: US Food and Drug Administration and manufacturer's website

Ibudone

September 20, 2008 by solo5010
Posted in

 A while back I asked a question about a 10/200mg hydro/IBU combo made by Qualitest/Vintage, because there package insert for the 5/200mg had the10/200 listed on it but no one had ever heard of it. Anyways through some surfing today I stumbled across Ibudone which is sold by proethic pharmaceucticals but is made by Vintage. So, it looks like theres a new hydro/ibu strength out there. 

New Generic OxyContin

September 20, 2008 by solo5010
Posted in

 Mallinckrodt was giving permission by Purdue Pharma to sell generic Oxy's starting in late Sept. 2008 through the end of 2009 and also received approval on July 24, 2008 by the FDA to make there generic OxyContin. They will be selling 10, 20, 40 and 80mg tablets. There appearance is as follows:

10mg Tablets- White round convex tablets M in a box on one side 593 on the other

20mg Tablets- Pink round convex tablets M in a box on one side 594 on the other

40mg Tablets-  Yellow round convex tablets M in a box on one side 595 on the other

80mg Talbets- Green round deeply convex tablets M in a box on one side 596 on the other 

Link to Prescribing Information 

Link to Press Release 

First-Time Generics - August 2008

September 10, 2008 by TP Admin
Posted in

First-Time Generic Approvals - August 2008

Tablets/Capsules Only
Generic
Drug Name		 Generic
Manufacturer		 Referenced
Brand Name		 Approval
Date		 Pill
Identification
GALANTAMINE TABLETS USP, 4 MG, 8 MG AND 12 MG BARR LABS RAZADYNE TABLETS 08-28-08 4 mg - round yellow B4 138; 8 mg - round pink B8 139; 12 mg - round red B12 140
GALANTAMINE TABLETS USP, 4 MG, 8 MG AND 12 MG ALPHAPHARM RAZADYNE TABLETS 08-28-08

Sources: US Food and Drug Administration and manufacturers' websites

First-Time Generics - July 2008

August 8, 2008 by TP Admin
Posted in

First-Time Generic Approvals - July 2008

Tablets/Capsules Only
Generic
Drug Name		 Generic
Manufacturer		 Referenced
Brand Name		 Approval
Date		 Pill
Identification
NISOLDIPINE EXTENDED-RELEASE TABLETS 20 MG 30 MG 40 MG MYLAN SULAR EXTENDED-RELEASE TABLETS 07-25-08 20 mg - round beige M N22; 30 mg - round orange M N23; 40 mg - round yellow M N24
MYCOPHENOLATE MOFETIL CAPSULES 250 MG ROXANE CELLCEPT CAPSULES, 250 MG 07-29-08
MYCOPHENOLATE MOFETIL CAPSULES 500 MG ROXANE CELLCEPT CAPSULES, 500 MG 07-29-08
DIVALPROEX SODIUM DELAYED-RELEASE TABLETS USP, 125 MG, 250 MG AND 500 MG DR. REDDY'S DEPAKOTE DELAYED-RELEASE TABLETS 07-29-08
DIVALPROEX SODIUM DELAYED-RELEASE TABLETS USP, 125 MG, 250 MG AND 500 MG SUN DEPAKOTE DELAYED-RELEASE TABLETS 07-29-08
DIVALPROEX SODIUM DELAYED-RELEASE TABLETS USP, 125 MG, 250 MG AND 500 MG GENPHARM DEPAKOTE DELAYED-RELEASE TABLETS 07-29-08
DIVALPROEX SODIUM DELAYED-RELEASE TABLETS USP, 125 MG, 250 MG AND 500 MG UPSHER-SMITH DEPAKOTE DELAYED-RELEASE TABLETS 07-29-08 125 mg - oblong rose U-S 180; 250 mg - oblong peach U-S 181; 500 mg - oblong pink U-S 182
DIVALPROEX SODIUM DELAYED-RELEASE TABLETS USP, 125 MG, 250 MG AND 500 MG SANDOZ DEPAKOTE DELAYED-RELEASE TABLETS 07-29-08 125 mg - round yellow SZ 492; 250 mg - oval rust SZ 493; 500 mg - oval white SZ 494
DIVALPROEX SODIUM DELAYED-RELEASE TABLETS USP, 125 MG, 250 MG AND 500 MG TEVA DEPAKOTE DELAYED-RELEASE TABLETS 07-29-08 125 mg - oval red brown 93 7439; 250 mg - oval beige 93 7440; 500 mg - oval pink 93 7441
DIVALPROEX SODIUM DELAYED-RELEASE TABLETS USP, 125 MG, 250 MG AND 500 MG LUPIN DEPAKOTE DELAYED-RELEASE TABLETS 07-29-08 125 mg - oval lavender L 005; 250 mg - oval lavender L 006; 500 mg - oval lavender L 006
EPLERENONE TABLETS 25 MG, 50 MG APOTEX INSPRA TABLETS, 25 MG AND 50 MG 07-30-08 25 mg - round yellow APO EP 25; 50 mg - round yellow APO EP 50

Sources: US Food and Drug Administration and manufacturers' websites

Pill imprints updated 09-10-08

First-Time Generics - June 2008

July 23, 2008 by TP Admin
Posted in

First-Time Generic Approvals - June 2008

Tablets/Capsules Only
Generic
Drug Name		 Generic
Manufacturer		 Referenced
Brand Name		 Approval
Date		 Pill
Identification
ZALEPLON CAPSULES, 5 MG AND 10 MG SANDOZ SONATA CAPSULES 06-06-08
ZALEPLON CAPSULES, 5 MG AND 10 MG GENPHARM SONATA CAPSULES 06-06-08
ZALEPLON CAPSULES, 5 MG AND 10 MG UNICHEM SONATA CAPSULES 06-06-08
ZALEPLON CAPSULES, 5 MG AND 10 MG AUROBINDO SONATA CAPSULES 06-06-08 5 mg - green E 19; 10 mg - green E 20
ZALEPLON CAPSULES, 5 MG AND 10 MG UPSHER-SMITH SONATA CAPSULES 06-06-08
ZALEPLON CAPSULES, 5 MG AND 10 MG TEVA SONATA CAPSULES 06-06-08 5 mg - green & white 93 5268; 10 mg - aqua blue & green 93 5269
ZALEPLON CAPSULES, 5 MG AND 10 MG ROXANE SONATA CAPSULES 06-06-08 5 mg - green 54 656; 10 mg - green 54 888
DRONABINOL CAPSULES,USP, 2.5 MG, 5 MG, AND 10 MG PAR MARINOL CAPSULES, 2.5 MG, 5 MG, 10 MG 06-27-08 2.5 mg - cream softgel Par 867; 5 mg - cream softgel Par 868; 10 mg - orange softgel Par 869
RISPERIDONE TABLETS USP, 0.25 MG, 0.5 MG, 1 MG, 2 MG, 3 MG, AND 4 MG TEVA RISPERDAL TABLETS 06-30-08 0.25 mg - round yellow 93 221; 0.5 mg - round red brown 93 225; 1 mg - round white 93 7240; 2 mg - round orange 93 7241; 3 mg - round yellow 93 7242; 4 mg - round green 93 7243

Sources: US Food and Drug Administration and manufacturers' websites

No more freebees

July 10, 2008 by Dr. Lois
Posted in

"Drug company sales representatives will have to stop doling out coffee mugs and pens that push their products when they visit doctor's offices. But they can still sneak in the occasional free lunch."

Thank goodness!!  No more pens, coffee cups, sticky notes, and paper clips that I do not need cluttering up the office!

First-Time Generics - May 2008

June 22, 2008 by TP Admin
Posted in

First-Time Generic Approvals - May 2008

Tablets/Capsules Only
Generic
Drug Name		 Generic
Manufacturer		 Referenced
Brand Name		 Approval
Date		 Pill
Identification
ROPINIROLE HYDROCHLORIDE TABLETS, 0.25 MG, 0.5 MG, 1

MG, 2 MG, 3 MG AND 4 MG

 MYLAN REQUIP TABLETS 05-05-08 2.5 mg - round white M N25; 0.5 mg - round yellow M N5; 1 mg - round green M N10; 2 mg - round orange M N20; 3 mg - round lavender M N30; 4 mg - grayish beige M N40
ROPINIROLE HYDROCHLORIDE TABLETS, 0.25 MG, 0.5 MG, 1

MG, 2 MG, 3 MG AND 4 MG

 ROXANE REQUIP TABLETS 05-05-08 2.5 mg - round white 54 511; 0.5 mg - round yellow 54 337; 1 mg - round green 54 751; 2 mg - round orange 54 231; 3 mg - round red 54 575; 4 mg - round brown 54 273
ACARBOSE TABLETS, 25 MG, 50 MG, AND 100 MG COBALT PRECOSE TABLET 05-07-08
DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS, 3 MG/0.03 MG; (28-DAY

REGIMEN)

 BARR YASMIN TALBETS 05-09-08
FLUOXETINE CAPSULES, USP 10 MG AND 20 MG TEVA SARAFEM PULVULES, 10 MG AND 20 MG 05-27-08 10 mg - purple capsule 93 7225; 20 mg - purple & flesh capsule 93 7226
OMEPRAZOLE DELAYED-RELEASE CAPSULES USP, 10 MG, 20 MG AND 40 MG ANDRX PRILOSEC DELAYED-RELEASE CAPSULES 05-30-08

Sources: US Food and Drug Administration and manufacturers' websites

Amerix

June 11, 2008 by mommy2two
Posted in

I am looking for info. on this drug. My Doc told me it is a extended release form of Flexeril. I am not getting any relief from this drug, no even sleep. I have tried it a couple of times and nothing. Could it be because I am on Ultram 100mg 4 X a day?

Ethex Oxycodone HCI

May 20, 2008 by anthonymon82
Posted in

I was looking on the Ethex website and found that they now have oxycodone hcl in 5mg, 10mg, 15mg, 20mg and 30mg strenths, that is great news for those who use it for breakthru meds, now you dont have to jump from 5 to 15 to 30mg. I have attached a link to their site..

http://www.ethex.com/oxy_portal/hcp/hcp_landing.aspx

 

Well just thougt it may interest someone

 

thanks anthony

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