Tuesday March 26, 2019

FDA Approves the New Generic EpiPen

Teva’s generic shot will be the first version that pharmacists can substitute even when doctors prescribe the original EpiPen

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EpiPen
A pharmacist holds a package of EpiPens epinephrine auto-injector, a Mylan product, in Sacramento, Calif., July 8, 2016. Mylan has a generic version of its emergency allergy treatment and a new competitor has been given FDA approval. (VOA)

U.S. health officials Thursday approved a new generic version of EpiPen, the emergency allergy medication that triggered a public backlash because of its rising price tag.

The new version from Teva Pharmaceuticals is the first that will be interchangeable with the original penlike injector sold by Mylan. The Food and Drug Administration announced the approval in a statement.

EpiPen injections are stocked by schools and parents nationwide to treat children with severe allergies. They are used in emergencies to stop potentially fatal allergic reactions to insect bites and stings and foods like nuts and eggs.

EpiPen maker Mylan has dominated the $1 billion market for the shots for two decades. Several other companies sell competing shots containing the drug epinephrine, but they aren’t heavily marketed or prescribed by doctors.

In 2016, Congress blasted Mylan in letters and hearings for raising EpiPen’s to $600 for a two-pack, a five-fold increase over nearly a decade. The company responded by launching its own lower-cost generic version for $300.

Mylan CEO
Mylan CEO Heather Bresch testifies, Sept. 16, 2016, before Congress over the cost of her company’s EpiPens. Lawmakers are outraged at high prescription drug costs, without acknowledging the role Congress may have played. (VOA)

Mylan continues to sell both versions at those prices, according to data from Elsevier’s Gold Standard Drug Database.

Teva’s generic shot will be the first version that pharmacists can substitute even when doctors prescribe the original EpiPen.

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A Teva spokeswoman declined to comment on the drug’s price but said it would launch “in the coming months.” Generic drugs can be priced as much as 80 percent lower than the original product. But those price cuts usually appear after several companies have launched competing versions.

Teva’s bid to sell a generic EpiPen faced multiple setbacks at the FDA, which rejected the company’s initial application in 2016. While epinephrine is a decades-old generic drug, Teva and other would-be competitors struggled to replicate the EpiPen’s auto-injector device. (VOA)

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FDA Approves Device to Treat Heart Failure Patients

The health body has granted approval of the Optimizer Smart system to US-based Impulse Dynamics

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www.fdalawyersblog.com

The US Food and Drug Administration has given approval for a new device that would help treat patients with life-threatening heart failure, and address an unmet need in patients who fail to get adequate benefits from standard treatments and have no alternative treatment options.

The Optimizer Smart system is comprised of several components, including an implantable pulse generator, battery charger, programmer and software. The pulse generator is implanted under the skin in the upper left or right area of the chest and connected to three leads that are implanted in the heart.

After the device is implanted, a physician tests and programmes the device, which delivers electrical impulses to the heart during regular heartbeats to help improve the heart’s squeezing capability.

The device would be beneficial for patients not suited to treatment with other heart failure devices such as cardiac resynchronisation therapy to restore a normal timing pattern of the heartbeat, the US FDA noted in a statement.

“Patients with moderate-to-severe chronic heart failure have limited treatment options. And for those who are unable to be treated due to underlying conditions or who have not responded to available treatments, their quality of life may be impacted, with limits on the types of physical activities they can do,” said Bram Zuckerman, Director at FDA’s Centre for Devices and Radiological Health.

Photo Credit: www.medscape.com

“The FDA recognised the unmet need for these patients and worked with the manufacturer…to efficiently bring this product to market, while ensuring it meets our regulatory requirements for safety and effectiveness,” Zuckerman added.

For the study, the US FDA evaluated data from two clinical trials with a total of 389 patients with moderate-to-severe heart failure.

All patients received optimal medical therapy and 191 patients also received an Optimizer Smart system implant.

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The Optimizer Smart system improves quality of life and functional status of certain heart failure patients.

The health body has granted approval of the Optimizer Smart system to US-based Impulse Dynamics. (IANS)