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Post by gerald on Jan 31, 2019 12:18:58 GMT -5
Hopefully the prices will be much better
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FDA Approves New Generic Treatment for Asthma, COPD Published Online: Wednesday, January 30th, 2019 The FDA has approved the first generic version of Advair Diskus (GlaxoSmithKline), a fluticasone propionate and salmeterol inhalation powder product. Approved for 100 mcg/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg doses, the generic drug (Wixela Inhub, Mylan) is indicated to treat patients with asthma and chronic obstructive pulmonary disease (COPD), including bronchitis and emphysema. The newly approved fluticasone propionate and salmeterol inhalation powder contains a corticosteroid and a long-acting beta(2)-adrenergic agonist (LABA) indicated for twice daily treatment of asthma in patients aged 4 years and older and maintenance treatment of airflow obstruction and reducing exacerbations in patients with COPD. This medicine is a complex drug-device combination product for which no generic product has been previously approved by FDA. Generic drugs are approved once they have met FDA’s rigorous approval standards to ensure the generic drug is as safe and effective as the brand name drug product. The generic must also meet the same quality requirements for manufacturing and packaging as the brand name drug product. FDA expedited the review of this abbreviated new drug application (ANDA) as a potential first generic. In the United States, 26 million people, including children, have asthma and  million people are living with COPD. According to the FDA, today’s approval should provide greater patient access to this medication. Reference FDA approves first generic Advair Diskus [news release]. Silver Spring, MD; January 30, 2019: FDA website. www.pharmacytimes.com/link/251. Accessed January 30,
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Post by skate4life on Feb 1, 2019 12:35:13 GMT -5
Yes that is good news IF there is a significant drop in price AND those with insurance and Medicare also see a drop in co-pay and tier level. Doubt we will see in the formularies before 2020.
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Post by gerald on Feb 1, 2019 17:49:27 GMT -5
Skate, In the end you are probably right. GlaxoSmithKline is already discounting Advair
in attempts to keep the generics out so the pricing should already by falling.
It appears that there should be three generic versions available by 2020, one might be available later this year but no one is committing. |
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Post by skate4life on Feb 2, 2019 10:28:59 GMT -5
Mylan is the company that massively increased the cost of the epi-pen. So don't hope for a low price  |
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Post by gerald on Feb 12, 2019 12:24:28 GMT -5
So the first generic is coming to market effect Feb 8
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Mylan (MYL) Launches Wixela Inhub, the First Generic of ADVAIR DISKUS ------------ Mylan N.V. (NASDAQ: MYL) today announced the launch of the first FDA-approved therapeutically equivalent, substitutable generic of ADVAIR DISKUS®, Wixela™ Inhub™ (fluticasone propionate and salmeterol inhalation powder, USP), approved by the U.S. Food and Drug Administration (FDA) through the Abbreviated New Drug Application (ANDA) pathway. Wixela Inhub is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD).
All three strengths of Wixela Inhub will be offered at a wholesale acquisition cost* 70% less than ADVAIR DISKUS and 67% less than GSK's authorized generic version which launched on Feb. 8. The wholesale acquisition costs of Wixela Inhub 100 mcg/50 mcg, 250 mcg/50 mcg and 500 mcg/50 mcg strengths are $93.71, $116.44 and $153.14, respectively.
Mylan's Chief Commercial Officer Tony Mauro commented, "We've had numerous discussions with customers about the need for a unique launch strategy for the first substitutable generic of ADVAIR DISKUS that increases affordability to all in our healthcare system. We trust that by launching Wixela Inhub at a significantly discounted list price, we will demonstrate the savings that generics can deliver for patients through reduced out-of-pocket costs, as well as the U.S. healthcare system overall."
In addition, Mylan will offer patient services to provide training and education about the treatment and device.
Wixela Inhub is indicated for the twice daily treatment of asthma in patients age 4 and older not adequately controlled on long-term asthma medications or whose disease warrants initiation of treatment with both inhaled corticosteroids and long-acting beta agonists; maintenance treatment of COPD; and the reduction of COPD exacerbations in patients with a history of exacerbations. It is not indicated for the relief of acute bronchospasm.
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Post by gerald on Feb 13, 2019 16:28:22 GMT -5
This shows the first prices on the generic. Not sure how that compares to the current name brand prices
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Generic Asthma, COPD Treatment Launched at Discounted List Price
FEBRUARY 12, 2019
Kristen Coppock, MA, Editor
The first FDA-approved generic version of Advair Diskus (GlaxoSmithKline [GSK]), a fluticasone propionate and salmeterol inhalation powder product, has been launched, Mylan N.V. announced today.1
Mylan’s product (Wixela Inhub) will be offered in 3 strengths at wholesale acquisition costs (WACs). The WACs for 100 mcg/50 mcg, 250 mcg/50 mcg and 500 mcg/50 mcg strengths are $93.71, $116.44 and $153.14, respectively.1
According to Mylan, its WACs for Wixela Inhub are 70% less than that of Advair Diskus and 67% less than GSK’s authorized generic equivalent, which was launched February 8, 2019.1
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Post by lavishgail on Feb 14, 2019 3:43:48 GMT -5
Oh my, Thank God My insurance pays for mine. I could never be able to buy it. My gosh.
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million people are living with COPD. According to the FDA, today’s approval should provide greater patient access to this medication.
