Alpharma To Withdraw And Resubmit Its New Drug Application For EMBEDA ( TM )

Alpharma Inc. ( NYSE: ALO ) , a global specialty pharmaceutical company, announced that it has withdrawn its New Drug Application ( 'NDA' ) for EMBEDA™ ( morphine sulfate extended-release with sequestered naltrexone hydrochloride ) Capsules, and plans to resubmit a revised application as soon as possible. While the initial NDA submission qualified for a priority review, certain technical issues around data presentation prevented a complete evaluation by U. S. Food and Drug Administration ( " FDA' ) within six month time period permissible for a priority review. The Company expects to address submission issues and re-qualify for priority review in its resubmission. Alpharma is fully committed to collaborating with Food and Drug Administration to complete a timely review of EMBEDA™ NDA, and continues to anticipate a first quarter 2009 launch following approval.

EMBEDA™ was developed with Alpharma's proprietary technology, which combines an extended release opioid with sequestered naltrexone, an opioid antagonist. In clinical trials, when EMBEDA™ was taken as directed, it provided effective pain relief and sequestered naltrexone passed through body without effect. When EMBEDA™ Capsule was crushed, chewed or dissolved, which are common approaches abusers use to tamper with product in order to gain euphoria, the naltrexone was released thereby significantly reducing euphoric effect of opioid.

Statements made in this press release include forward-looking statements within meaning of the Private Securities Litigation Reform Act of 1995. These statements, including those relating to future financial expectations, involve certain risks and uncertainties that could cause actual results to differ materially from those in forward-looking statements. Information on other important potential risks and uncertainties not discussed herein may be found in Company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for year ended December 31, 2007.

About Alpharma

Alpharma Inc. ( NYSE: ALO ) is a global specialty pharmaceutical company with leadership positions in products for humans and animals. Alpharma is presently active in more than 80 countries. Alpharma has a growing branded pharmaceutical franchise in U. S. pain market with its KADIAN� ( morphine sulfate extended-release ) Capsules, and FLECTOR� Patch ( diclofenac epolamine topical patch ) . Alpharma is also internationally recognized as a leading provider of pharmaceutical products for poultry and livestock.

Alpharma

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Levitra: uses

Levitra is used to treat male sexual function problems ( impotence or erectile dysfunction ) by blocking a certain enzyme ( phosphodiesterase-PDE5 ) . In combination with sexual stimulation, Levitra works by helping blood flow into penis to achieve and maintain an erection.

Levitra isn't indicated for use in women.

Use of Levitra does not protect against sexually transmitted diseases ( e. g. , HIV, hepatitis B, gonorrhea, syphilis ) . Practice " safe sex " such as using latex condoms. Consult your doctor or pharmacist for more details.

Levitra: how to use

Levitra is taken by mouth as needed, 1 hour before sexual activity with or without food; or use as directed by your doctor. Don't take more often than once daily as needed.

A high fat meal may decrease amount of drug that's absorbed.

Avoid eating grapefruit or drinking grapefruit juice while you're being treated with Levitra unless your doctor instructs we otherwise.

The dosage is based on your medical condition, response to therapy, and other medications we may be taking ( see also Drug Interactions section ) . Consult your doctor or pharmacist for more details.

Read the patient information leaflet provided by your pharmacist and ask questions if any of the information is unclear.

Levitra: side effects

Headache, flushing, nasal stuffiness, stomach upset, heartburn, runny nose, dizziness, or nausea may occur while use Levitra. Vision changes such as increased sensitivity to light, blurred vision, or impaired blue/green color discrimination may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed Levitra because he or she has judged that benefit to we is greater than risk of side effects. Many people using Levitra don't have serious side effects.

Rarely, a sudden loss of eyesight in one or both eyes ( NAION ) may occur while use Levitra. This may or mayn't be due to Levitra. If this serious problem occurs, seek immediate medical attention. You have a slightly greater chance of developing this serious eye problem if we have heart disease, diabetes, high cholesterol, certain eye problems ( " crowded disk " ) , high blood pressure, are over 50 years of age, or if we smoke.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur:

Sexual activity may put extra strain on your heart, especially if we have heart problems. If we have heart problems and experience any of these serious side effects while having sex, stop and tell your doctor immediately of:

For males, in very unlikely event we have a painful or prolonged erection lasting 4 or more hours, stop using Levitra and seek immediate medical attention, or permanent problems could occur.

Rarely, Levitra may cause sudden hearing problems, or ringing in ears. Stop taking Levitra and tell your doctor immediately if these effects occur.

A serious allergic reaction to Levitra is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include:

This is not a complete list of possible side effects. If we notice other effects not listed above, contact your doctor or pharmacist.

Levitra: precautions

Before taking Levitra, tell your doctor or pharmacist if we are allergic to it; or if you have any other allergies.

Before using Levitra, tell your doctor or pharmacist your medical history, especially of:

Levitra may make you dizzy or cause vision changes; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

Caution is advised when using Levitra in elderly because they may be more sensitive to the side effects of drug.

Levitra is not indicated for use in women or children.

Levitra: interactions

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring we for them. Don't start, stop, or change the dosage of any medicine before checking with them first.

See also How To Use section for drug-food interactions.

Levitra shouldn't be used with following medications because very serious ( possibly fatal ) interactions may occur:

If we are currently using any of these medications, tell your doctor or pharmacist before starting Levitra.

Before using Levitra, tell your doctor or pharmacist of all prescription and nonprescription/herbal products we may use, especially of:

If you are taking ritonavir or nelfinavir, don't take more than a 2. 5mg dose of Levitra in a 72 hour period. If you are taking indinavir or high doses ( 400mg daily ) of either ketoconazole or itraconazole, do not take more than a 2. 5mg dose of Levitra per day. If we are taking erythromycin or low doses ( 200mg daily ) of either ketoconazole or itraconazole, don't take more than 5mg dose of Levitra per day. For more details contact your doctor or pharmacist.

Other drugs besides Levitra which may affect the heart rhythm ( QTc prolongation in the EKG ) include dofetilide, pimozide, amiodarone, quinidine, sotalol, procainamide, and sparfloxacin among others. QTc prolongation can infrequently result in serious, rarely fatal, irregular heartbeats. Consult your doctor or pharmacist for details before taking Levitra. Ask for instructions about whether you need to stop any other QTc-prolonging drugs we may be using in order to minimize risk of this effect.

This document doesn't contain all possible interactions. Therefore, before using Levitra, tell your doctor or pharmacist of all the products we use. Keep a list of all your medications with you, and share list with your doctor and pharmacist.

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