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New drugs recently approved by the FDA.

New Medication

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Has anyone ever heard of the new drug called "snail" comes from the ocean and is suppose to help chronic pain tremendously it is non narcotic and is suppose to be non habit forming anyone has any info please let me know thanks.

 Stephanie

Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP

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PRINCETON, N.J., Aug. 20 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc.
(RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL),
announced today that RLL has received approval from the U.S. Food and Drug
Administration to manufacture and market Hydrocodone Bitartrate and
Acetaminophen Tablets USP, 7.5 mg/750 mg, 10 mg/500 mg, 5 mg/500 mg, and 10
mg/325 mg strengths. The Office of Generic Drugs, U.S. Food and Drug
Administration, has determined the Ranbaxy formulations to be bioequivalent
and have the same therapeutic effect as that of the reference listed drugs
as follows: 10 mg/325 mg Norco Tablets of Watson Pharmaceuticals Inc., 5
mg/500 mg Vicodin Tablets, and 7.5 mg/750 mg Vicodin ES Tablets both of
Abbott Laboratories, and 10 mg/500 mg Lortab Tablets of UCB Inc. Total
annual market sales for Hydrocodone Bitartrate and Acetaminophen Tablets
were $390.6 million (IMS - MAT: June 2007).
"Hydrocodone Bitartrate and Acetaminophen Tablets are indicated for the
relief of moderate to moderately severe pain, and Ranbaxy is pleased to
receive final FDA approval for multiple strengths of this product. These
approvals further expand our product portfolio of affordable generic
alternatives and will be launched in a November 2007 time period to all
classes of trade," according to Jim Meehan, Vice President of Sales and
Marketing for RPI.
Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, is a
wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India's
largest pharmaceutical company. RPI is engaged in the sale and distribution
of generic and branded prescription products in the U.S. healthcare system.
Ranbaxy Laboratories Limited, headquartered in India, is an integrated,
research based, international pharmaceutical company producing a wide range
of quality, affordable generic medicines, trusted by healthcare
professionals and patients across geographies. Ranbaxy's continued focus on
R&D has resulted in several approvals in developed markets and significant
progress in New Drug Discovery Research. The Company's foray into Novel
Drug Delivery Systems has led to proprietary "platform technologies",
resulting in a number of products under development. The Company is serving
its customers in over 125 countries and has an expanding international
portfolio of affiliates, joint ventures and alliances, ground operations in
49 countries and manufacturing operations in 11 countries.
*Vicodin(R) ES Tablets is a registered trademark of Abbott Laboratories
*Norco(R) Tablets is a registered trademark of Watson Pharmaceuticals Inc.
*Lortab(R) Tablets is a registered trademark of UCB Inc.

CONTACTS: Charles M. Caprariello
Vice President, Corporate Communications
Ranbaxy Inc.
(609) 720-5615

Edwige Buteau
RF Binder Partners Inc.
(212) 994-7517
edwige.buteau@rfbinder.com

Anuj Baveja
RF Binder Partners Inc.
(212) 994-7552
anuj.baveja@rfbinder.com

First-Time Generics - June 2007

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First-Time Generic Approvals - June 2007

Tablets/Capsules Only
Generic
Drug Name
Generic
Manufacturer
Referenced
Brand Name
Approval
Date
BENZONATATE CAPSULES USP, 100 MG AND 200 MG ZYDUS TESSALON PERLES 06-08-07
TRETINOIN CAPSULES 10 MG BARR LABS VESANOID CAPSULES, 10 MG 06-21-07
PAROXETINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 12.5 MG (BASE) AND 25 MG (BASE) MYLAN PAXIL CR EXTENDED-RELEASE TABLETS 06-29-07

Source: US Food and Drug Administration

First-Time Generic Lamisil Approvals

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On July 2, 2007, the US Food and Drug Administration approved the first generic versions of Lamisil (terbinafine hydrochloride), a drug that treats nail fungus infections. Several manufacturers will market terbinafine in 250 mg tablet form.

According to news releases by Teva Pharmaceuticals and Roxane Laboratories, total annual sales of Lamisil are approximately $685 million.

At this time little information is available regarding pill imprints. If known, drug descriptions are listed below in our table of approved manufacturers. We will update the list as more information becomes available.

Terbinafine Hydrochloride Approvals

Pill Identification by Manufacturer
Manufacturer Tablet Description Pill Imprint
Actavis Round white Logo 101
Amneal Round white AN 543
Apotex Round white APO TER 250
Aurobindo Round white D 74
Dr. Reddy's Round white R 250
Gedeon Richter
Genpharm
Glenmark
InvaGen Round white IG 209
Mylan Oblong white M 571
Orgenus
Roxane Round white 54 744
Teva Round white 93 7294
Watson Round white WPI 3322
Wockhardt Round white W 743
Sandoz Round white T

Sources: US Food and Drug Administration and Manufacturers' Websites

Imprints updated 02-25-08

First-Time Generics - May 2007

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First-Time Generic Approvals - May 2007

Tablets/Capsules Only
Generic
Drug Name
Generic
Manufacturer
Referenced
Brand Name
Approval
Date
METOPROLOL SUCCINATE EXTENDED RELEASE TABLETS USP, 50 MG SANDOZ TOPROL XL EXTENDED RELEASE TABLETS 50 MG 05-18-07
METOPROLOL SUCCINATE EXTENDED RELEASE TABLETS USP, 100 MG AND 200 MG KV PHARMACEUTICAL TOPROL XL EXTENDED RELEASE TABLETS 100 MG AND 200 MG 05-18-07
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULES, 2.5 MG (BASE)/10 MG, 5 MG (BASE)/10 MG, 5 MG (BASE)/20 MG, AND 10 MG (BASE)/20 MG TEVA LOTREL CAPSULES 05-18-07

Source: US Food and Drug Administration

New uber drug or just hype?

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I know that it seems preachy and off-topic but please, bear with me.

Due to a slight case of insomnia i often find myself looking at strange things on that there inter-web. More macabre than adult (usually) and wondering if its worth the time to do a little online investigation, and before i know it its 9:30 am and i have found my self posting q's on a new website. This one however really took my interest. I came along a "picture" of a chupacabra and looked around and found ..... long story a little shorter, Santa Rosa Institute for Advanced Genetics from a cheesy little site by the name of the FVZA , or Federal VAMPIRE and ZOMBIE Association . They say that this institute is making pills from genetic Vampire blood. One named ENVIGOR helps one not sleep for around 48+ hrs with little or no effects. The other Genuflux is designed to reverse the "horrors" of aging. The link below will bring you to the Santa Rosa site. i guess i'm really just trying to find someone who knows about up and coming drugs, and can tell me yes or no. Common sense says no if they are made from vampire blood, lol. But i dont see something like this popping into society for a little while longer into the future. I mean come on,....an anti-aging pill? A stay up for two days and be a little tired, pill? I just don't know. Please help me Obiwan Kenobi, You're our only hope......you know what anyone please!!!!!

http://www.srigenetics.com/

First-Time Generics - April 2007

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First-Time Generic Approvals - April 2007

Tablets/Capsules Only
Generic
Drug Name
Generic
Manufacturer
Referenced
Brand Name
Approval
Date
NIMODIPINE CAPSULES, 30 MG SUN PHARMA NIMOTOP CAPSULES 04-17-07
ZOLPIDEM TARTRATE TABLETS, 5 MG AND 10 MG SYNTHON AMBIEN TABLETS 04-23-07
ZOLPIDEM TARTRATE TABLETS, 5 MG AND 10 MG APOTEX AMBIEN TABLETS 04-23-07
ZOLPIDEM TARTRATE TABLETS, 5 MG AND 10 MG RANBAXY AMBIEN TABLETS 04-23-07
ZOLPIDEM TARTRATE TABLETS, 5 MG AND 10 MG DR. REDDY'S AMBIEN TABLETS 04-23-07
ZOLPIDEM TARTRATE TABLETS, 5 MG AND 10 MG MYLAN AMBIEN TABLETS 04-23-07
ZOLPIDEM TARTRATE TABLETS, 5 MG AND 10 MG ROXANE AMBIEN TABLETS 04-23-07
ZOLPIDEM TARTRATE TABLETS, 5 MG AND 10 MG WATSON AMBIEN TABLETS 04-23-07
ZOLPIDEM TARTRATE TABLETS, 5 MG AND 10 MG PAR AMBIEN TABLETS 04-23-07
ZOLPIDEM TARTRATE TABLETS, 5 MG AND 10 MG CARLSBAD AMBIEN TABLETS 04-23-07
ZOLPIDEM TARTRATE TABLETS, 5 MG AND 10 MG GENPHARM AMBIEN TABLETS 04-23-07
ZOLPIDEM TARTRATE TABLETS, 5 MG AND 10 MG MUTUAL AMBIEN TABLETS 04-23-07
ZOLPIDEM TARTRATE TABLETS, 5 MG AND 10 MG CARACO AMBIEN TABLETS 04-23-07
ZOLPIDEM TARTRATE TABLETS, 5 MG AND 10 MG LEK AMBIEN TABLETS 04-23-07
ZOLPIDEM TARTRATE TABLETS, 5 MG AND 10 MG TEVA AMBIEN TABLETS 04-23-07
PRAVASTATIN SODIUM TABLETS, 10 MG, 20 MG, 40 MG, AND 80 MG RANBAXY PRAVACHOL TABLETS 04-23-07

Source: US Food and Drug Administration



Pharmer.org Pill Identifier - Zolpidem Imprints

Tovalt ODT

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On April 25, 2007, the US Food and Drug Administration approved Tovalt ODT (zolpidem tartrate orally disintegrating tablets) made by Biovail. Tovalt ODT is considered a new drug with no therapeutic equivalent. Zolpidem tartrate is the active ingredient in Ambien, a prescription medication used for short-term treatment of insomnia.

Two days earlier the FDA granted approval to several generic companies to manufacture non-orally disintegrating zolpidem tartrate (generic Ambien).

Consumers now have a choice among brand name Ambien, brand name Tovalt ODT and generic Ambien. While this is good news for consumers, are two different delivery forms of the same medication necessary? Is there an advantage to an ODT form versus a drug with an onset of approximately 30 minutes? If you have any pertinent comments, please post and let us know what you think.

Pill Identification - TOVALT ODT

5 mg zolpidem tartrate orally disintegrating - white round tablets imprinted ZT on one side and 5 on the other side

10 mg zolpidem tartrate orally disintegrating - blue round tablets imprinted ZT on one side and 10 on the other side

First-Time Generics - March 2007

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First-Time Generic Approvals - March 2007

Tablets/Capsules Only
Generic
Drug Name
Generic
Manufacturer
Referenced
Brand Name
Approval
Date
Pill
Identification
MOEXIPRIL HCL AND HYDROCHLOROTHIAZIDE TABLETS, 7.5 MG/12.5 MG, 15 MG/12.5 MG, AND 15 MG/25 MG TEVA UNIRETIC TABLETS 03-07-07 7.5/12.5 mg - oblong yellow tablet 93 5213; 15/12.5 mg - oblong white tablet 93 5214; 15/25 mg - oblong yellow tablet 93 5215
CIPROFLOXACIN ER TABLETS, 500 MG AND 1000 MG MYLAN CIPRO XL TABLETS 03-22-07 500 mg - oblong orange tablet M 1743; 1000 mg - oblong orange tablet M 1745
NADOLOL AND BENDROFLUMETHIAZIDE TABLETS USP, 40 MG/5 MG AND 80 MG/5 MG IMPAX CORZIDE TABLETS 03-30-07

Source: US Food and Drug Administration

Janumet

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On April 2, 2007, the US Food and Drug Administration approved Janumet, a new drug that treats type 2 diabetes. Janumet combines sitagliptin (the active ingredient in Januvia) and metformin (a commonly prescribed antihyperglycemic agent) to better control blood sugar in patients who do not respond to monotherapy with either drug. Merck & Co. is the manufacturer of Janumet.

According to Merck approximately 21 million people in the US have diabetes, with type 2 diabetes comprising about 90 percent of the total. Type 2 diabetes is usually treated with diet and exercise. If lifestyle modifications fail to control blood sugar, an oral anti-diabetic medication is then prescribed.

For more information, please see the Janumet website.

Pill Identification - JANUMET

50 mg sitagliptin/500 mg metformin - light pink capsule-shaped film-coated tablets imprinted 575

50 mg sitagliptin/1000 mg metformin - red capsule-shaped film-coated tablets imprinted 577

Patient Information - JANUMET

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