Generic Drug Approvals

Generic Drug Approvals. First-Time Generic Approvals. Mobic, Propecia, Zithromax

Cialis, Viagra and Levitra to Treat ED (continued)


July 22nd, 2008 by admin


Warning

Call your doctor or seek emergency treatment immediately if you experience any of the following symptoms:
Rash
Painful erection
Prolonged erection (longer than 4 hours)
Fainting
Chest pain
Itching or burning during urination

Stop taking these medications and call a doctor or health care provider right away if you experience sudden or decreased vision loss in one or both eyes. A rare vision problem called NAION has been reported by a few men using these drugs. NAION (nonarteritic anterior ischemic optic neuropathy) causes a sudden loss of eyesight because blood flow is blocked to the optic nerve. People who have a higher chance for NAION include those who:
Are over 50 years old
Smoke
Have heart disease
Have diabetes
Have high blood pressure
Have high cholesterol
Have certain eye problems
How Should These Drugs Be Stored?

These drugs should be kept in its original container and out of reach of children. Store them away from excess heat and moisture (not in the bathroom). Discard any medication that has expired or is no longer needed.

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Erectile Dysfunction: Cialis, Viagra and Levitra to Treat ED


July 10th, 2008 by admin


There are only three oral drugs approved by the FDA to treat erectile dysfunction: Cialis, Levitra, and Viagra. All work by increasing the flow of blood into the penis so that when a man is sexually stimulated, he can get an erection.
What Are the Differences Between Cialis, Levitra, and Viagra?

Cialis, Levitra, and Viagra work by a similar mechanism to cause erections. There are subtle differences in how long the drug works and how quickly it works. Levitra works a little longer than Viagra. They both take effect in about 30 minutes. With Levitra, the effects last for about 5 hours. With Viagra, the effects last approximately 4 hours.

Cialis works a bit faster (within about 15 minutes), and the effects last much longer — up to 36 hours in some cases.
If One of These Drugs Isn’t Effective for Erectile Dysfunction, Can I Try Another?

Yes, but because these drugs work the same way, it’s unlikely that you’ll have success with one if you’ve failed to achieve an adequate erection with another.
What Precautions Should I Take Before Taking One of These Drugs?

There are certain situations in which these drugs may not be safe to take. Before taking them, tell your doctor:
If you are allergic to any drugs, including Viagra or other ED medications.
About any prescription or nonprescription medications you are currently taking, including herbal and dietary supplements.
If you are scheduled for surgery, including dental surgery.
If you take nitroglycerin or a long-acting nitrate to treat chest pain. The combination of Cialis, Levitra or Viagra with these drugs can cause dangerously low blood pressure.
If you take alpha-blockers for blood pressure or prostate problems. The combination of Cialis or Levitra with these drugs can also cause dangerously low blood pressure.

In addition, always follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any part that you do not understand. Take these drugs exactly as directed. Do not take more or less or take it more often than prescribed by your doctor. Do not take these drugs more than once a day.
Who Should Not Take Cialis, Levitra or Viagra?

If you have suffered from a heart attack, stroke or life threatening arrhythmia (irregular heart rate) within the last 6 months you should discuss other options with your doctor. It is also advised to avoid these drugs if you have uncontrolled high or low blood pressure or if you experience chest pain with sex.
What Are the Side Effects of Cialis, Levitra and Viagra?

Side effects are not common but they can occur. Side effects can include:
Headache
Upset stomach or ‘heartburn’
Flushing (feeling warm)
Nasal congestion
Changes in vision (color, glare)
Back pain (with Cialis)

Call your doctor if you experience severe forms of these symptoms or if they do not go away after 4-8 hours.

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Azithromycin Info


June 29th, 2008 by admin


Azithromycin is an azalide, a subclass of macrolide antibiotics. Azithromycin (brand names Zithromax in Italy, The United Kingdom, The United States, Australia, Portugal and Belgium; ATM in India, Zithromac in Japan, Vinzam / Zitromax in Spain; Zmax; Sumamed; Aztrin, Zitrocin, Azibiot, Azifine,AziCip) is one of the world’s best-selling antibiotics, and is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring, thus making the lactone ring 15-membered. Azithromycin is used to treat certain bacterial infections, most often those causing middle ear infections, tonsillitis, throat infections, laryngitis, bronchitis, pneumonia and sinusitis. It is also effective against certain sexually transmitted infectious diseases, such as non-gonococcal urethritis and cervicitis. Recent studies have also indicated it to be effective against late-onset asthma, but these findings are controversial and not widely accepted yet.

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Mobic (Meloxicam) - Description


June 17th, 2008 by admin


Meloxicam, an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each pastel yellow MOBIC tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Each bottle of MOBIC oral suspension contains 7.5 mg meloxicam per 5 mL. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N -(5-methyl-2-thiazolyl)-2 H -1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C14H13N3O4S2 and it has the following structural formula.

Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n -octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2.

MOBIC is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam, and as an oral suspension containing 7.5 mg meloxicam per 5 mL.

The inactive ingredients in Mobic® (meloxicam) tablets include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate.

The inactive ingredients in Mobic® (meloxicam) oral suspension include colloidal silicon dioxide, hydroxyethylcellulose, sorbitol, glycerol, xylitol, monobasic sodium phosphate (dihydrate), saccharin sodium, sodium benzoate, citric acid (monohydrate), raspberry flavor, and purified water.

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FDA OKs Once-Daily Cialis


June 4th, 2008 by admin


Men taking the erectile dysfunction drug Cialis may now take a low dose of the drug on a daily basis.

The FDA has approved once-daily use of Cialis in a dose of 5 milligrams or a new 2.5-milligram dose for the treatment of erectile dysfunction (ED).

Once-daily Cialis “may be most appropriate for men with ED who anticipate more frequent sexual activity (e.g. twice weekly),” states a news release from Eli Lilly and Company, which makes Cialis.

“For other men, Cialis taken as needed — the previously approved dosing regimen — may be most appropriate,” the drug company notes.

The FDA approved the once-daily Cialis dosing plan on based three studies in which 2.5-milligram or 5-milligram daily doses of Cialis trumped a placebo pill. In those studies, men took Cialis every day without regard to the timing of their sexual activity.

The FDA first approved Cialis in 2003 in doses of 5 milligrams, 10 milligrams, and 20 milligrams.

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Generic Drug Economics


May 27th, 2008 by admin


The principal reason for the relatively low price of generic medicines is that these companies incur fewer costs in creating the generic drug, and are therefore able to maintain profitability while offering the drug at a lower cost to consumers. The costs of these generic drugs are so low that many developing countries can easily afford. For example Thailand is going to import millions of generic version pills of Plavix, a blood-thinning treatment to prevent heart attacks, costs just 3 US cents per pill from India, the leading manufacturer of generic drugs.

Generic manufacturers do not incur the cost of drug discovery, and instead are able to reverse-engineer known drug compounds to allow them to manufacture bioequivalent versions. Generic manufacturers also do not bear the burden of proving the safety and efficacy of the drugs through clinical trials, since these trials have already been conducted by the brand name company. In most countries, generic manufacturers must only prove that their preparation is bioequivalent to the existing drug in order to gain regulatory approval. It has been estimated that the average cost to brand-name drug companies of discovering and testing a new innovative drug (with a new chemical entity) may be as much as $800 million.[1] However, these estimations are strongly disputed as much too high.

Generic drug companies may also receive the benefit of the previous marketing efforts of the brand-name drug company, including media advertising, presentations by drug representatives, and distribution of free samples. Many of the drugs introduced by generic manufacturers have already been on the market for a decade or more, and may already be well-known to patients and providers (although often under their branded name).

Prior to the expiration of a drug patent, a brand name company enjoys a period of “market exclusivity” or monopoly, in which the company is able to set the price of the drug at the level which maximizes profitability. This price often greatly exceeds the production costs of the drug, which can enable the drug company to make a significant profit on their investment in research and development. The advantage of generic drugs to consumers comes in the introduction of competition, which prevents any single company from dictating the overall market price of the drug. With multiple firms, the profit-maximizing price generally reflects the ongoing cost of producing the drug, which is usually much lower than the monopoly price.

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Wikipedia: generic drug


May 15th, 2008 by admin


A generic drug (pl. generic drugs, short: generics) is a drug which is produced and distributed without patent protection. A generic must contain the same active ingredients as the original formulation. In most cases, it is considered bioequivalent to the brand name counterpart with respect to pharmacokinetic and pharmacodynamic properties. By extension, therefore, generics are assumed to be identical in dose, strength, route of administration, safety, efficacy, and intended use. In most cases, generic products are not available until the patent protections afforded to the original developer have expired. When generic products become available, the market competition often leads to substantially lower prices for both the original brand name product and the generic forms. The time it takes a generic drug to appear on the market varies. Drug patents give twenty years of protection, but they are applied for before clinical trials begin, so the effective life of a drug patent tends to be between seven and twelve years.

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Columbia Encyclopedia: generic drug


May 3rd, 2008 by admin


A drug sold or prescribed under the nonproprietary name of its active ingredients or under a generally descriptive name rather than under a brand or trade name. The name of the active ingredient is established by a government or international body, and is typically the U.S. Adopted Name, British Approved Name, or International Nonproprietary Name. Generic drugs must contain the same active ingredients that their brand name counterparts do and are tested to assure that they are therapeutically equivalent, but they may contain different inactive ingredients from those found in the brand name medications.

There are generic versions of both over-the-counter and prescription medications, but not all drugs have generic equivalents. Generic drugs can only be produced when a patent on a brand name drug expires or when a patent has never existed. They are generally cheaper than the equivalent brand name drug because of much lower marketing and development costs. Because a generic competitor can hurt a brand name manufacturer’s profits, drug companies have used legal action and regulatory delays to slow the introduction of generics, or have paid generic manufacturers to postpone the production and marketing of generics. The Medicare overhaul legislation passed in 2003 contained sections designed to speed the introduction of generic drugs by making it easier to challenge weak or invalid drug patents.

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When can a generic drug be produced?


April 28th, 2008 by admin


When a pharmaceutical company first markets a drug, it is usually under a patent that allows only the pharmaceutical company that developed the drug to sell it. Generic drugs can be legally produced for drugs where: 1) the patent has expired, 2) the generic company certifies the brand company’s patents are either invalid, unenforceable or will not be infringed, 3) for drugs which have never held patents, or 4) in countries where a patent(s) is/are not in force.[citation needed] The expiration of a patent removes the monopoly of the patent holder on drug sales licensing. Patent lifetime differs from country to country, and typically there is no way to renew a patent after it expires. A new version of the drug with significant changes to the compound could be patented, but this requires new clinical trials and does not prevent the generic versions of the original drug.

This allows the company to recoup the cost of developing that particular drug. After the patent on a drug expires, any pharmaceutical company can manufacture and sell that drug. Since the drug has already been tested and approved, the cost of simply manufacturing the drug will be a fraction of the original cost of testing and developing that particular drug.

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Generic Drugs Economics


April 20th, 2008 by admin


The principal reason for the relatively low price of generic medicines is that competition increases among producers when drugs no longer are protected by patents. Companies also incur fewer costs in creating the generic drug, and are therefore able to maintain profitability while offering the drug at a lower cost to consumers. The costs of these generic drugs are so low that many developing countries can easily afford them. For example Thailand is going to import millions of pills of the generic version of Plavix, a blood-thinning treatment to prevent heart attacks, at a cost of 3 US cents per pill from India, the leading manufacturer of generic drugs.

Generic manufacturers do not incur the cost of drug discovery, and instead are able to reverse-engineer known drug compounds to allow them to manufacture bioequivalent versions. Generic manufacturers also do not bear the burden of proving the safety and efficacy of the drugs through clinical trials, since these trials have already been conducted by the brand name company. In most countries, generic manufacturers must only prove that their preparation is bioequivalent to the existing drug in order to gain regulatory approval. It has been estimated that the average cost to brand-name drug companies of discovering and testing a new innovative drug (with a new chemical entity) may be as much as $800 million.

Generic drug companies may also receive the benefit of the previous marketing efforts of the brand-name drug company, including media advertising, presentations by drug representatives, and distribution of free samples. Many of the drugs introduced by generic manufacturers have already been on the market for a decade or more, and may already be well-known to patients and providers (although often under their branded name).

Prior to the expiration of a drug patent, a brand name company enjoys a period of “market exclusivity” or monopoly, in which the company is able to set the price of the drug at the level which maximizes profitability. This price often greatly exceeds the production costs of the drug, which can enable the drug company to make a significant profit on their investment in research and development. The advantage of generic drugs to consumers comes in the introduction of competition, which prevents any single company from dictating the overall market price of the drug. With multiple firms, the profit-maximizing price generally reflects the ongoing cost of producing the drug, which is usually much lower than the monopoly price.

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