FDA Approves First Nonprescription Daily Oral Contraceptive - FDA.gov

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According to the announcement:

"[T]he U.S. Food and Drug Administration approved Opill (norgestrel) tablet for nonprescription use to prevent pregnancy— the first daily oral contraceptive approved for use in the U.S. without a prescription. Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online."

Read the full news release:  FDA Approves First Nonprescription Daily Oral Contraceptive - FDA.gov

U.S. approves sale of over-the-counter hearing aids - Reuters

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According to the article:

"The Food and Drug Administration on Tuesday approved the sale of over-the-counter hearing aids, allowing millions of Americans to buy hearing aids without seeing an audiologist and potentially saving individuals thousands of dollars.

The rules, which take effect in mid-October, apply to hearing aids for people with mild to moderate hearing loss. The aids will be available directly from stores or online without medical exams, a prescription or audiologist fitting adjustment."

Read the full source article: U.S. approves sale of over-the-counter hearing aids - Reuters

Go to the FDA NEWS RELEASE - FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans - More Affordable Hearing Aids Could Be in Stores as Soon as Mid-October

FDA Authorizes First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19 - FDA. gov

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According to the news release:

"Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older. 

“Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” said FDA Commissioner Stephen M. Hahn, M.D. “As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes.” "

Read the full news release:

Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19 - Test is authorized for individuals two years of age or older, including those not showing symptoms - FDA.gov

Sex Supplements - Containing Viagra; Other Issues

Sex supplements often contain Viagra ingredients | Reuters:

"Herbal supplements aimed at improving men's sexual abilities often contain the active ingredients in erectile dysfunction pills such as Viagra, according to a new study.

Additionally, researchers found that some of these over-the-counter herbal remedies contained more of the ingredient than is allowed in prescription-only pharmaceuticals."

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FDA Notes Primatene Mist Departure

Medical News: FDA Notes Primatene Mist Market Departure - in Product Alert, OTC from MedPage Today:     'via Blog this'

The only over-the-counter asthma inhaler sold in the United States will no longer be available next year as part of a phase-out of epinephrine inhalers containing chlorofluorocarbons (CFCs).

Epinephrine CFC inhalers, marketed as Primatene Mist, are being phased out because they use CFCs as a propellant (spray) to move the medicine out of the inhaler so patients can breathe the medicine into their lungs. 

Primatene Mist is approved by the Food and Drug Administration (FDA) for the temporary relief of occasional symptoms of mild asthma.

If you're a Primatene Mist user, the FDA recommends that you see a health care professional soon to get another medicine. A doctor, physician assistant, or nurse practitioner can all help you determine the best treatment option for you. Primatene Mist may be harder to find on store shelves even before Dec. 31, 2011.

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Hangover Cure - Caffeine and Anti-Inflammatories

This just in.

Treat your hangover with caffeine and non-steroidal anti-inflammatory drugs, says this MSNBC news article, And the definitive hangover cure is ... plain old coffee and aspirin, actually.

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Johnson and Johnson GMP Headache - Insights

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Updated December 25, 2020

Links in the original post broke.

You might also be interested in:

Why J&J's headache won't go away - Fortune

- - -  the original post follows below  - - -

This investigative report by Mina Kimes offers insights into Johnson and Johnson's quality control breakdowns, Why J&J's headache won't go away. This appears to be the same article published in Fortune magazine's September 6, 2010 issue.

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Electronic Orange Book Online

Updated Aug 18, 2016:

FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)

Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition

You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

- - - original post below - - -

The FDA offers an electronic (online) version of the Orange Book, also known as Approved Drug Products with Therapeutic Equivalence Evaluations.

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FDA Cautions About Sexual Enhancement Supplements

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Updated February 2, 2021

Links in the original post broke.

People also ask about:

Tainted Sexual Enhancement Products - FDA.gov

- - -  original post follows below  - - -

The FDA offers these words of advice to patients, Caution about Sexual Enhancement Supplements.

An FDA investigation of a number of these sexual enhancement products found that a third of them actually contained the same or similar ingredients as those in Viagra (sildenafil citrate), Cialis (tadalafil), and Levitra (vardenafil HCl) - and sometimes in very large amounts. FDA has issued many alerts about these products over the past several years, but their number appears to be growing.

In a nutshell:

• Patients who should not take approved prescription drugs for erectile dysfunction should not take these sexual enhancement products, because they could pose similar or worse risks.
• Patients who are using prescription drugs to treat erectile dysfunction should not to take these so-called "supplements" because doing so could expose them to dangerously high doses of the active ingredient in their prescriptions.

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FDA Says Watch Out For Fake Alli Capsules

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The U.S. Food and Drug Administration (FDA) is warning consumers about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit).  The counterfeit Alli product looks similar to the authentic product, with a few notable differences. The counterfeit Alli has:

• Outer cardboard packaging missing a “Lot” code;
• Expiration date that includes the month, day, and year (e.g., 06162010); authentic Alli expiration date includes only the month and year (e.g.,: 05/12);
• Packaging in a plastic bottle that has a slightly taller and wider cap with coarser ribbing than the genuine product;
• Plain foil inner safety seal under the plastic cap without any printed words; the authentic product seal is printed with “SEALED for YOUR PROTECTION”;
• Contains larger capsules with a white powder, instead of small white pellets.

Consumers who believe they have received counterfeit Alli are asked to contact the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site (http://www.fda.gov/OCI).

Related Posts:
Counterfeits In The Global Drug Supply

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Cheerios Aside . . . FDA Gives Guidance On OTC Labels (pdf)

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Updated April 21, 2020

The link broke in the original post.

You might also be interested in:
FDA Guidance for Industry - Labeling OTC Human Drug Products — Questions and
Answers (PDF)  found on this FDA webpage  Labeling OTC Human Drug Products -- Questions and Answers

- - -  original post follows below  - - -

OK, now that we can chuckle about the Cheerios label fiasco, here's the scoop on what should go on OTC labels, "FDA Guidance for Industry - Labeling OTC Human Drug Products (PDF)"

In a nutshell, the Food and Drug Administration (FDA) has prepared this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act. It is intended to help small businesses better understand the new over-the-counter (OTC) labeling requirements set forth in 21 CFR 201.66 and prepare new labeling.

If you're new to this arena, you'll find this a real eye opener. The FDA even regulates things down to the detail of what size font you need to use, and more!

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FDA Publishes Rulemaking Histories For OTC Drugs

If you're in the Over-The-Counter (OTC), non-prescription drug business, then this FDA collection might be of some interest to you: Rulemaking History for Nonprescription Products: Drug Category List. The Over-the-Counter (OTC) drug category collection contains Federal Register notices organized by therapeutic category subtopics. Each child collection links to therapeutic category pages organized chronologically. Pretty nice. For example, you can scan the Federal Register history for something like, Hair Growth and Loss, Male Genital Desensitizers, or Weight Control. 

Related Posts: FDA Warning - Anesthetics On Skin Can Harm FDA Alert - Bowel Cleanser Warning Cold Meds For Kids - The FDA Weighs In Again 

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FDA Must Consider Dropping Age Limit For Morning After Pill

The FDA let politics cloud its judgment when it denied teenage girls over-the-counter access to the Plan B morning-after pill, a federal judge said Monday as he ordered the FDA to let 17-year-olds obtain the medication. The judge ruled the agency had improperly bowed to political pressure from the Bush Administration when it set 18 as the age limit in 2006. U.S. District Judge Edward R. Korman in New York instructed the agency to make Plan B available to 17-year-olds within 30 days and to review whether to make the emergency contraceptive available to all ages without a doctor's order, reports this Washington Post news article, "FDA Ordered to Rethink Age Restriction for Plan B - Judge Says Politics Influenced Policy on the Contraceptive." What a polarizing firestorm this is going to create! What do you think?! 

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Easy FDA Orange Book Search Widget

Updated Aug 18, 2016:
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)

Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition

You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

- - - original post below - - -

You can perform your FDA Orange Book searches on the FDA's site, or you can use this Search Orange Book Widget to conduct your searches using a single interface. No more switching back and forth between multiple web pages! I used the widget as is, at the link location above. Some of you more tech savvy folks might consider installing the widget. Here's what the widget creator says . . .

by viswanathaa
Created 10/28/08
With all search options conveniently under one window, this widget allows one to search the US FDA electronic orange book faster & from your own homepage.

Happy hunting!

Related Posts:
FDA Orange Book - Online
About The FDA Orange Book - Slide Deck (free)

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FDA Warning - Anesthetics On Skin Can Harm

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Updated October 6, 2022

The link in the original post broke.

You can still read about this topic here:

FDA Issues Public Health Advisory Alert on Skin Numbing Products - OH&S Online

---  the original post follows below  ---

According to the FDA press release, FDA Alerts Public about Danger of Skin Numbing Products, popular topical anesthetics (that is, skin numbing drugs) can cause severe reactions when used improperly. The alert talks about serious and life-threatening risks associated with improper use of topical anesthetics available in over-the-counter (OTC) and prescription forms of these drugs. These skin-numbing products in cremes, ointments or gels contain anesthetic drugs such as lidocaine, tetracaine, benzocaine, and prilocaine that are used to desensitize nerve endings near the skin's surface. If used improperly, the drugs can be absorbed into the bloodstream and cause reactions such as irregular heartbeat, seizures, breathing difficulties, coma or even death. Here are some details you should read . . .

The FDA strongly advises consumers not to:

• make heavy application of topical anesthetic products over large areas of skin
• use formulations that are stronger or more concentrated than necessary
• apply these products to irritated or broken skin
• wrap the treated skin with plastic wrap or other dressings
• apply heat from a heating pad to skin treated with these products.

If a health professional recommends the use of a topical anesthetic, then:

• use a topical anesthetic that contains the lowest strength, and amount, of medication that will relieve the pain
• apply the topical anesthetic sparingly and only to the area where pain exists or is expected to occur
• do not apply the topical anesthetic to broken or irritated skin
• ask your healthcare professional what side effects are possible and how to lower the chance of having life-threatening side effects from anesthetic drugs
• be aware that wrapping or covering the skin treated with topical anesthetics with any type of material or dressing can increase the chance of serious side effects, as can applying heat to the treated area while the medication is still present

Did you learn anything new here? What are you going to do differently for yourself, or for your loved ones for safety's sake? 

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Serious Drug Interaction Risks For Older Adults (video)

If you are, or know an older adult, taking medications, then you should read this. Researchers from the University of Chicago Medical Center report that at least one in 25 older adults, about 2.2 million people in the United States, take multiple drugs in combinations that can produce a harmful drug-drug interaction, and half of these interactions involve a non-prescription medication. This WRAL.com video gives you the major highlights, "Mixing medications poses risks (video)."

For further reading on the subject:

• JAMA Abstract - Use of Prescription and Over-the-counter Medications and Dietary Supplements Among Older Adults in the United States
• Press Release - Older adults at high risk for drug interactions - More attention needed for non-prescription meds - and provides a table listing the most common potentially severe medication interactions found

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FDA Alert - Bowel Cleanser Warning

This is something you should read if you do 'cleanses' or are preparing for GI (gastrointestinal) or a colonoscopy procedure. Many of these related products can be found everywhere, including the corner drug store, so be aware. Read this FDA news release for the full details, "FDA Requires New Safety Measures for Oral Sodium Phosphate Products to Reduce Risk of Acute Kidney Injury Risk associated with both prescription and over-the-counter (OTC) products. The greatests risk are associated with . . .

• people over 55 years of age,
• people who suffer from dehydration, kidney disease, acute colitis, or delayed bowel emptying, and
• people taking certain medicines that affect kidney function, such as diuretics (fluid pills), angiotensin converting enzyme inhibitors (medications that lower blood pressure) angiotensin receptor blockers, (used to treat high blood pressure, heart or kidney failure) and possibly nonsteroidal anti-inflammatory drugs (similar to ibuprofen and other arthritis medications).
• FDA also warns that products should not be used by children under 18 years of age or in combination with other laxative products containing sodium phosphate

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Cold Meds For Kids - The FDA Weighs In Again

This is probably my last post on this subject, yet a worthy close to this thread. If you've been following this issue you'll want to read this FDA statement, "FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children."

In a nutshell, there are still a lot of issues that need to get resolved. In the meantime, here's the abbreviated version of what the FDA recommends:

• Do not give children medications labeled only for adults.
• Talk to your healthcare professional if you have any questions about using cough or cold medicines in children.
• Choose OTC cough and cold medicines with child-resistant safety caps, when available.
• Check the "active ingredients" section of the DRUG FACTS label of the medicines that you choose.
• Be very careful if you are giving more than one medicine to a child.
• Carefully follow the directions for how to use the medicine in the DRUG FACTS part of the label.
• Only use measuring devices that come with the medicine or those specially made for measuring drugs.
• Understand that using OTC cough and cold medicines does not cure the cold or cough.

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