First generic EpiPen gets FDA approval

The US Food and Drug Administration has ...

Posted: Aug 17, 2018 9:38 AM
Updated: Aug 17, 2018 9:38 AM

The US Food and Drug Administration has approved the first generic competitor to EpiPen and EpiPen Jr. for the emergency treatment of allergic reactions in adults and children.

The company Teva Pharmaceuticals gained approval to market the new generic drug, according to an announcement from the FDA on Thursday.

Allergies

Business and industry sectors

Business, economy and trade

Companies

Diseases and disorders

Government organizations - US

Health and medical

Mylan

Pharmaceutical industry

Pharmaceuticals and biotechnology

Pharmaceuticals and prescription drugs

US Department of Health and Human Services

US federal departments and agencies

US Food and Drug Administration

Immunology

Medical fields and specialties

Drug safety, efficacy and availability

Drug shortages

Brendan O'Grady, executive vice president who heads North America Commercial at Teva, noted in an emailed statement Thursday that the approval "marks an important step forward in bringing our patients additional prescription medications that have met the FDA's rigorous standards."

"We're applying our full resources to this important launch in the coming months and eager to begin supplying the market," the statement said.

No details are available regarding the cost of the new generic or precisely when it will be available.

'A lower-cost option'

The approval of the generic drug comes after EpiPens were added to the FDA's drug shortage list in May and two years after the maker of EpiPen, pharmaceutical company Mylan, increased costs of its product by more than 400%, leading to public outrage.

The newly approved generic offers an alternative for patients who, until now, have been able to use only the brand-name EpiPen.

"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," FDA Commissioner Dr. Scott Gottlieb said in the announcement.

"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," he said.

EpiPen is an auto-injector that delivers epinephrine, more commonly known as adrenaline, a hormone that can help relax muscles in the airways and tighten blood vessels. It can open the airways and reduce swelling during a severe allergic reaction.

Epinephrine injection is used along with emergency medical treatment for life-threatening reactions caused by allergies to insect bites or stings, foods, medications, latex or other causes.

Yet "the path to developing generic drug-device combination products like this one is challenging," Gottlieb said, because combination drugs consist of two parts: the drug, such as epinephrine, and the device, such as the auto-injector.

"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," Gottlieb said.

This effort is part of the administration's overarching aim to "remove barriers to generic development," as outlined in its Drug Competition Action Plan, announced last year.

"We're especially committed to the development of generic copies of complex products," Gottlieb said. "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."

He added that "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."

What this means for back-to-school planning

Before the new generic, the only other FDA-approved alternatives to EpiPen were the brand products Auvi-Q and Adrenaclick. The newly approved option made by Teva is the only approved non-brand option.

The American Academy of Allergy, Asthma, and Immunology is "very pleased" with the approval of the new generic, said Dr. Robert Wood, president of the academy and director of pediatric allergy and immunology at Johns Hopkins Medicine in Baltimore.

"Any measures that can improve the availability and costs of these medications is a real benefit for our patients," Wood said.

"There have been recent concerns about shortages of EpiPens, which has been especially an issue as families are refilling prescriptions for back-to-school planning," he said. "We strongly support any measures than can help provide these lifesaving medications in a more cost-effective manner, especially given the concerns about the shortages of EpiPens."

Mississippi Coronavirus Cases

Data is updated nightly.

Confirmed Cases: 27900

Reported Deaths: 1082
CountyConfirmedDeaths
Hinds215239
DeSoto137316
Madison122234
Jones106949
Neshoba96069
Lauderdale88278
Rankin84112
Forrest81442
Scott75015
Harrison7448
Copiah56615
Leake54819
Jackson53316
Holmes52741
Wayne52112
Washington4969
Lee49316
Oktibbeha48624
Yazoo4736
Leflore47249
Lowndes45311
Warren44317
Lincoln43534
Lamar4197
Grenada3805
Monroe36729
Pike36712
Attala35223
Lafayette3524
Newton3289
Sunflower3066
Covington3025
Bolivar27713
Panola2706
Adams26718
Chickasaw25918
Tate2577
Jasper2506
Marion24811
Pontotoc2476
Noxubee2458
Pearl River24432
Winston2435
Clay24210
Claiborne23610
Simpson2303
Smith20611
Clarke20124
Marshall2013
Coahoma1866
Kemper17614
Union1759
Walthall1724
Yalobusha1617
Carroll16011
Lawrence1591
Itawamba1278
Calhoun1244
Humphreys1239
Tippah12311
Webster12310
Montgomery1222
Hancock12013
Jefferson Davis1064
Tallahatchie1043
Prentiss983
Greene927
Jefferson923
Wilkinson919
Tunica893
Amite822
George743
Choctaw714
Quitman680
Tishomingo681
Perry614
Alcorn561
Stone521
Franklin382
Benton270
Sharkey240
Issaquena71
Unassigned00

Alabama Coronavirus Cases

Confirmed Cases: 39604

Reported Deaths: 961
CountyConfirmedDeaths
Jefferson4387142
Montgomery383999
Mobile3697134
Tuscaloosa204938
Marshall153710
Lee118937
Shelby108223
Madison10577
Morgan9813
Walker86723
Franklin85213
Dallas8198
Elmore81314
Baldwin6869
Etowah62513
Butler60427
DeKalb6025
Chambers58127
Tallapoosa56369
Autauga54511
Unassigned52025
Russell4840
Lowndes45820
Lauderdale4446
Houston4344
Limestone4090
Cullman4003
Pike3995
Colbert3685
Bullock3629
Coffee3532
Barbour3231
Covington3087
St. Clair3042
Hale29321
Marengo28611
Wilcox2808
Sumter27612
Calhoun2705
Talladega2677
Clarke2665
Escambia2636
Dale2440
Jackson2382
Winston2333
Blount2141
Chilton2112
Pickens2116
Marion20312
Monroe1972
Choctaw19212
Conecuh1804
Bibb1711
Macon1708
Randolph1709
Greene1667
Perry1451
Henry1303
Crenshaw1233
Lawrence1010
Washington1007
Cherokee747
Lamar711
Fayette671
Geneva670
Clay582
Coosa551
Cleburne291
Out of AL00
Tupelo
Clear
84° wxIcon
Hi: 86° Lo: 74°
Feels Like: 90°
Columbus
Clear
77° wxIcon
Hi: 90° Lo: 73°
Feels Like: 78°
Oxford
Few Clouds
88° wxIcon
Hi: 87° Lo: 73°
Feels Like: 100°
Starkville
Clear
73° wxIcon
Hi: 88° Lo: 70°
Feels Like: 73°
WTVA Radar
WTVA Temperatures
WTVA Severe Weather