Sentences with phrase «epipen products»

«You failed to thoroughly investigate multiple serious component and product failures for your EpiPen products, including failures associated with patient deaths and severe illness,» the warning read.

We are very confident in the safety and efficacy of EpiPen products being produced at the site.»

The U.S. Food and Drug Administration (FDA) has given Pfizer's (pfe) Meridian Medical Technologies unit a warning over multiple violations at the Brentwood, Mo. manufacturing plant where it makes EpiPen products for Mylan (myl).

«Your own data show that you received hundreds of complaints that your EpiPen products failed to operate during life - threatening emergencies, including some situations in which patients subsequently died,» the FDA wrote.

Not exact matches

The Food and Drug Administration (FDA) under Commissioner Scott Gottlieb is continuing its quest to ramp up generic drug approvals, this time for complex generics that could compete with products such as Mylan's EpiPen.

Its brand has become synonymous with Kleenex and other household products when it comes to fighting deadly allergies; in fact, the EpiPen enjoys a near - monopoly on the market with annual sales of more than $ 1.3 billion and nearly 90 % U.S. market share in the space.

Nor did Mylan pledge to refrain from raising the price of EpiPen further, something it has already been exploring since the product's main competitor Auvi - Q went off the market last year.

There are two main parts to the investigation: 1) whether or not Mylan engaged in «product hopping,» or making small tweaks to the EpiPen in order to preserve IP protection; and 2) whether or not the pharma giant entered into certain agreements that stalled the entry of cheaper generics into the market.

Mylan said last month that it would introduce the first generic version of EpiPen for $ 300, half the price of the branded product, as it tries to quell the backlash.

After all, Mylan acquired the EpiPen from another company, and while Bresch insists that significant improvements have been made to the epinephrine - delivering product itself, she also admitted on Thursday that a big part of the price increase rationale was to fund marketing and awareness efforts for the device.

She poured marketing resources into the product, and embarked on an awareness and political campaign to get more EpiPens into schools and other public institutions.

In a statement Monday, Mylan says it has tried to make EpiPen accessible and affordable to people who really need it, offering rebate cards that allowed 80 % of patients with commercial insurance to get the product for free last year.

What's more, Bresch, citing the roughly $ 600 wholesale cost, added that when you look at other treatments, the EpiPen does not fall into the category of «an expensive product.»

A lot of that growth came from increasing EpiPen prescriptions as the product became more mainstream: In the first seven years Mylan owned EpiPen, the number of patients using it grew 67 %, according to Bloomberg.

Mylan said it expects to launch the generic product «in several weeks» at a list price of $ 300 per generic EpiPen, compared with the branded product's cost of about $ 600.

This company reduced the out - of - pocket costs of EpiPen for some patients last week amid a wave of criticism from lawmakers and the public over the rapid escalation in the product's price in the past few years.

«Mylan has spent billions of dollars making EpiPen a household name synonymous with epinephrine, but there are lesser - known products such as generic Adrenaclick, which can be purchased for approximately $ 140 for a two - pack,» said Senate Health Committee Chairman Kemp Hannon, a Long Island Republican.

Insulin and insulin - loaded dispensing products (vials, jet injectors, biojectors, epipens, infusers and preloaded syringes)

The TGA says that while it can encourage companies with EpiPen - like products to apply to market them in Australia, the government has no powers to force them to do so — «it is a commercial decision».

In addition, a third company is looking to enter the Australian market with an EpiPen - like product in the middle of 2018.