Mylan to Offer Generic EpiPen

MONDAY, Aug. 29, 2016 — A cheaper generic version of the emergency allergy treatment EpiPen will be made available within the next few weeks, manufacturer Mylan said Monday.

In the wake of mounting criticism over recent price hikes, the company said the generic version will be distributed by its U.S. subsidiary. It will have a list price of $ 300 for a two-pack, compared with $ 608 for the brand-name version. The generic version will be available in both 0.15 milligram (mg) and 0.30 mg strengths, the Associated Press reported.

EpiPens are used to treat anaphylaxis — a severe, potentially fatal allergic reaction to insect bites and foods like nuts and eggs.

The auto-injection device, which contains the hormone epinephrine, expires after a year. Since most users need several — one for home, and one for school or work, for example — the costs can mount up.

With just one competitor, Mylan has a near monopoly on the device. Now, the company is being accused of price gouging after significantly increasing the EpiPen price in recent years.

The list price for the pack of two was a little more than $ 100 when Mylan first bought the device in 2007. Most of the increase — from $ 265 to more than $ 600 — has come in the last three years, The New York Times reported.

Health insurance doesn’t necessarily help all people who need EpiPens, because those with high deductibles must pay almost the total price.

Some politicians have called for: Congressional hearings on the escalating pricing, an investigation by the Federal Trade Commission, and action by the U.S. Food and Drug Administration to increase competition by hastening approvals of competitors’ products, the AP reported.

EpiPens have been marketed since the 1980s, and some observers have also questioned why Mylan still holds a patent. The patent applies to the device itself, not the active ingredient.

At least two companies are seeking approval to sell a rival brand or generic version of EpiPen in the United States, but none are likely to be available until later next year.

However, the compounding pharmacy Imprimis Pharmaceuticals said it may have a version available for individual patients in a few months. It said it would likely charge about $ 100 for two injectors, the AP reported.

More information

The American Academy of Pediatrics has more about treating anaphylaxis.

Mylan to Offer Generic EpiPen

Mylan announces cheaper generic EpiPens amid price-gouging accusations

Mylan says it will make available a generic version of its EpiPen, as criticism mounts over the price of its injectable medicine.

The company said on Monday that its US subsidiary will put out a generic version of the EpiPen that will have a list price of $ 300 for a two-pack – about half the current price. It will be available in both 0.15mg and 0.30mg strengths.

The company charges $ 608 for a two-pack of the branded EpiPen. Mylan said it will keep in place the $ 300 savings card for the branded EpiPen and the revised patient assistance program announced last week.

Consumers and politicians have accused the company of price-gouging, considering that the product has been on the market since 1987 and the price didn’t start rising significantly until Mylan acquired it in 2007. There is also little competition, with the only rival product being Adrenaclick, which carries a list price of $ 461.

Mylan chief executive Heather Bresch has defended the price hikes, saying the company only received $ 274 of the total price for a twin-package while insurers, pharmacies and other parties divvy up the rest.

EpiPens are used in emergencies to treat severe allergies to insect bites and foods like nuts and eggs that can lead to anaphylactic shock. People usually keep a number of EpiPens handy at home, school or work. The syringes, prefilled with the hormone epinephrine, expire after a year.

Mylan said it anticipated having the generic versions available in the next several weeks. It will continue to market and distribute a branded EpiPen.

Numerous members of Congress and other politicians this week have called for congressional hearings on Mylan’s pricing, an investigation by the Federal Trade Commission and action by the Food and Drug Administration to increase competition by speeding up approvals of any rival products.

At least two companies are trying to get US approval to sell a rival brand or generic version of EpiPen. None is likely to hit the US market until well into next year. Relief could come sooner from Imprimis Pharmaceuticals, a compounding pharmacy that prepares medicines to fill individual prescriptions. It said it might be able to sell a version in a few months and would probably charge around $ 100 for two injectors.

Last week, the actress Sarah Jessica Parker terminated her role as a spokesperson for Mylan.

Mylan announces cheaper generic EpiPens amid price-gouging accusations

FDA Recalls Another Batch Of Generic Metoprolol

The FDA has recalled far more than 13,000 bottles of metoprolol succinate extended release tablets manufactured by Dr. Reddy’s Laboratories. Two months in the past the agency recalled yet another great deal of generic metoprolol from a various organization, Wockhardt. Each recalls had been for medicines manufactured at amenities in India. There have been a number of reviews in current many years of difficulties with generic drugs produced in India.

The recalls had been categorized as Class II, which the FDA says “may cause short-term or medically reversible adverse wellness consequences or exactly where the probability of critical adverse well being consequences is remote.”

A story in the New York Times details the long-simmering and increasing considerations of Cleveland Clinic cardiologist Harry Lever in excess of generic metoprolol. Lever reported his worries to the FDA and attempted to get Congress concerned. “Dr. Lever could not prove that the generic medication were to blame,” writes Katie Thomas. “’You see ample individuals and you get a truly feel, but it’s anecdotes. It’s not science’,” he told the Occasions. “Now, Dr. Lever is feeling a type of sad vindication.”

FDA Recalls Another Batch Of Generic Metoprolol