The U.S. Food and Drug Administration approved the first generic versions of Aricept (donepezil hydrochloride) orally disintegrating tablets on Dec. 11. Donepezil hydrochloride is indicated for the treatment of dementia related to Alzheimer’s disease.

Although other generic versions of donepezil hydrochloride are already available, the orally disintegrating tablets dissolve on the tongue, without having to be swallowed whole. This may make it easier to take the medication for older or disabled patients who have difficulty swallowing.  

“Generics offer greater access to health care for all Americans,” said Gary Buehler, director of the FDA’s Office of Generic Drugs. “Health care professionals and consumers can be assured that FDA-approved generic drugs have met the same rigorous standards as the brand-name drug  and are the same as the branded in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.” 

Alzheimer’s disease is an irreversible, progressive brain disease that slowly destroys memory and thinking skills and, eventually, the ability to carry out the simplest tasks of daily living. In most people with Alzheimer’s disease, symptoms first appear after age 60. Alzheimer’s disease is the most common cause of dementia among older people, but it is not a normal part of aging.

Dementia refers to a decline in cognitive function that interferes with daily life and activities. Alzheimer’s disease starts in a region of the brain that affects recent memory, then gradually spreads to other parts of the brain.

The generic donepezil hydrochloride orally disintegrating tablets, manufactured by Mutual Pharmaceutical of Philadelphia, have been approved in 5 milligram and 10 mg strengths.

Disclaimer : This information is for reading and knowledge purpose only and should not be considered or interpreted as medical advise. 

The U.S. Food and Drug Administration (FDA) has approved Pennsaid Topical Solution (diclofenac sodium topical solution) for the treatment of the signs and symptoms of osteoarthritis of the knee.

What is said about Pennsaid ?

Pennsaid Topical Solution is in a group of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). It works by reducing hormones that cause inflammation and pain in the body.

Pennsaid is used to treat the signs and symptoms of osteoarthritis of the knee(s).

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have a history of stomach ulcer or bleeding, liver or kidney disease, high blood pressure, fluid retention or congestive heart failure.

While the risk of absorbing Pennsaid into your bloodstream is low, all non-steroidal anti-inflammatory drugs (NSAIDs) can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use Pennsaid just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

Apply Pennsaid to clean, dry skin. Dispense Pennsaid 10 drops at a time either directly onto the knee or first into the hand and then onto the knee. Spread Pennsaid Topical Solution evenly around front, back and sides of the knee. Repeat this procedure until 40 drops have been applied and the knee is completely covered with solution. After you apply Pennsaid, wait at least 10 minutes before dressing. Do not bathe or shower for at least 30 minutes after applying Pennsaid. Wait until the area is completely dry before covering with clothing or applying sunscreen, insect repellent, cosmetics, topical medications, or other substances.

Do not cover the treated skin with a bandage or expose it to heat from a hot tub, heating pad, sauna, or heated water bed. Heat or bandaging can increase the amount of drug you absorb through your skin and may cause harmful effects. Do not use Pennsaid on an open skin wound, or on areas of eczema, infection, skin rash, or burn injury. Wait until the condition has fully healed before using Pennsaid.

Pennsaid side effects -

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. This is not a complete list of side effects and others may occur. Although the risk of serious side effects is low when diclofenac is applied to the skin, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream.

Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088. Further reading at http://www.pharm-education.com/2009/12/fda-approves-pennsaid-diclofenac-sodium.html .

Disclaimer : The above information has been cited from literature in public domain. This is for research purpose/ dissemination of knowledge only and should not be construed as medical advise. 

The 505(b)(2) Drug Development Pathway:

The 505(b)(2) regulation offers an attractive pathway to cheaper and faster new drug development, particularly to a manufacturer with experience in developing generic products. It involves making significant changes to an existing FDA approved product, called reference product, to create a new product with its own indication, formulation, population, and/ or other differences that need to be supported with clinical studies. A major advantage of this pathway is that it allows a sponsor to rely, at least in part, on the FDA’s findings of safety and/or effectiveness for a previously approved drug, thereby reducing the number of clinical trials required for approval. The biggest incentive to develop 505(b)(2) products is 3-5 years of market exclusivity, depending on the extent of change to the previously approved drug and type of clinical data included in the approval application (NDA). However, like all drug development strategies, 505(b)(2) pathway requires careful consideration and planning taking into account all the potential issues to be addressed before embarking on development. These issues include intellectual property concerns, supporting information available either from reference products or literature, the logistics of conducting clinical trials with generic-like products, market competition for approved products and business considerations for international product launch.

Need to know when and how to take Advantage of a Unique American Regulatory Pathway ?

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