The U.S. Food and Drug Administration today approved the
first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for
the emergency treatment of allergic reactions, including those that are
life-threatening (anaphylaxis), in adults and pediatric patients who weigh more
than 33 pounds. Teva Pharmaceuticals USA gained approval to market its generic
epinephrine auto-injector in 0.3 mg and 0.15 mg strengths.
“Today’s approval of the first generic version of the
most-widely prescribed epinephrine auto-injector in the U.S. is part of our longstanding
commitment to advance access to lower cost, safe and effective generic
alternatives once patents and other exclusivities no longer prevent approval,”
said FDA Commissioner Scott Gottlieb, M.D. “This approval means patients living
with severe allergies who require constant access to life-saving epinephrine
should have a lower-cost option, as well as another approved product to help
protect against potential drug shortages. The path to developing generic
drug-device combination products like this one is challenging. We remain
committed to doing our part to provide scientific and regulatory clarity for
sponsors seeking to develop complex generics, as well as prioritize the
approval of medicines with little or no generic competition as part of our overarching
effort to remove barriers to generic development and market entry of critically
important medicines. Many of these steps were outlined in our Drug Competition
Action Plan, announced last year. We’re especially committed to the development
of generic copies of complex products. These products can be hard to copy, and
therefore sometimes don’t face timely generic competition once patents and
exclusivities are no longer a block to approval. We’re advancing new guidance
for sponsors to make the development of generic versions of complex products
more efficient, and we’re prioritizing review of many complex generic drug
applications.”
Life-threatening allergies can include reactions to insect
bites or stings, foods, medications, latex or other causes. Anaphylaxis is a
medical emergency that affects the whole body and, in some cases, leads to
death. Anaphylaxis occurs in approximately one in 50 Americans. People who have
had an anaphylaxis episode always face the risk of another one. Because of this
risk, they must carry an emergency dose of epinephrine at all times. Many must
keep more than one dose at hand.
The EpiPen is intended to automatically inject a dose of
epinephrine into a person’s thigh to stop an allergic reaction. The FDA has
approved several epinephrine auto-injector products under new drug applications
to treat anaphylaxis, including EpiPen, Adrenaclick and Auvi-Q. In addition,
“authorized generic” versions of EpiPen and Adrenaclick are marketed without
the brand names. An authorized generic is made under the brand name’s existing
new drug application using the same formulation, process and manufacturing
facilities that are used by the brand name manufacturer. The labeling or
packaging is, however, changed to remove the brand name or other trade dress.
In some cases, a company may choose to sell an authorized generic at a lower
cost than the brand-name drug product.
Epinephrine auto-injector products are known as “combination
products” because they consist of a drug (epinephrine) and a device (the
auto-injector). The development of generic combination products can be more
challenging than typical drug products, and the FDA regularly takes steps to
help guide industry through the process. The agency works with individual
companies to support their development of such complex products, and creates
publicly available guidance describing the steps the FDA recommends companies
take to submit complete, approvable applications for various types of medical
products. In this case, the FDA has published three draft or final guidances
since 2009 related to the development of generic epinephrine auto-injectors. In
addition, as with brand-name drugs, the FDA inspects manufacturing and
packaging facilities for generic drugs to ensure that they are capable of consistently
producing quality products.
This epinephrine injection (auto-injector) is intended for
immediate administration to patients. When given intramuscularly or
subcutaneously, it has a rapid onset and short duration of action. Epinephrine
works by reducing swelling in the airway and increasing blood flow in the
veins.
The most common side effects associated with epinephrine
injection are anxiety, apprehensiveness, restlessness, tremor, weakness,
dizziness, sweating, palpitations, pallor, nausea and vomiting, headache and/or
respiratory difficulties. Rare cases of serious skin and soft tissue infections
have been reported following use of the drug. In patients with heart disease,
use of epinephrine injection may cause chest pain (angina pectoris) or abnormal
heart beats (ventricular arrhythmias). Following use of epinephrine injection,
patients should seek immediate medical or hospital care. Epinephrine should not
be injected into the vein, buttock, fingers, hands or feet. To minimize risk of
injection-site injury, movement of the leg should be limited during injection.
The agency requires appropriate data and information to
demonstrate that complex drug-device combination products meet the FDA’s
rigorous approval standards to ensure quality drug products that are safe and
effective are available to patients.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM617173.htm
The FDA has approved generic versions of the EpiPen and
EpiPen Jr epinephrine autoinjectors.
Why this matters
Nongeneric versions of the autoinjectors have been the
subject of steep and controversial price increases.
These generic versions are expected to offer a low-cost
alternative for consumers.
Key highlights
Epinephrine autoinjectors allow for rapid injection of an
appropriate dose of the drug to stop an allergic reaction and forestall
life-threatening anaphylaxis.
Parents of children with allergies associated with
anaphylaxis often must provide schools with a pair of unexpired autoinjectors
for the child to attend school.
People with allergies associated with anaphylactic responses
are recommended to have an autoinjector with them at all times.
Some people may even need to have more than 1 dose
available.
About 1 in 50 people in the United States has experienced
anaphylaxis.
A generic version of the Adrenaclick autoinjector is also
available.
The patient population for this latest generic version of an
epinephrine autoinjector, produced by Teva Pharmaceuticals USA, is adults and
pediatric patients who weigh more than 33 pounds.
The autoinjector is available at 0.3 and 0.15 mg strengths.
The EpiPen autoinjector is the most widely prescribed of the
autoinjectors, according to an FDA statement.
. http://univadis.com/player/yiqrtjmes?m=1_20180817&partner=unl&rgid=5wrwdwuxiebgkifdvytwbgmcqa&ts=2018081700&o=tile_01_id
See: http://childnervoussystem.blogspot.com/2016/08/shades-of-questcor-3.html
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