Shares in Mylan (NSDQ:MYL) fell yesterday after the company missed earnings expectations but beat sales estimates on Wall Street with its fourth-quarter financial results. The Pittsburgh, PA-based company posted profits of $51.2 million, or 10¢ per share, on sales of $3.04 billion for the three months ended Dec. 31, for bottom-line loss of -79% on sales loss […]
Mylan launches generic sublingual film for opioid dependence
Mylan (NSDQ:MYL) said today that it launched its buprenorphine and naloxone sublingual film as a generic of Indivior‘s (LON:INDV) Suboxone sublingual film. The product is indicated for the treatment of opioid dependence. The therapy should be used alongside counseling and psychosocial support for people living with opioid dependence, according to Mylan. Get the full story at our […]
Teva aims for 25% of U.S. EpiPen market by 2020
Teva (NYSE:TEVA) expects its generic EpiPen auto-injector to claim 25% of the U.S. market by the end of this year, according to a report from Seeking Alpha. For years, Mylan‘s (NSDQ:MYL) brand-name emergency allergy device has dominated the markets. But the company faced widespread criticism in 2016 when reports revealed that Mylan hiked the price of the EpiPen […]
Touting pricetag, Mylan launches Advair generic
Mylan (NSDQ:MYL) today announced the launch of its Wixela Inhub product, a generic for GlaxoSmithKline‘s (NYSE:GSK) Advair Diskus device, for people with asthma or chronic obstructive pulmonary disease. The company touted that its device’s list price is 70% less than Advair Diskus and 67% less than GSK’s generic. Get the full story at our sister site, Drug Delivery […]
Mylan wins race for generic Advair approval
FDA has approved the first generic of GlaxoSmithKline‘s (NYSE:GSK) blockbuster Advair respiratory drug, this one by Mylan (NSDQ:MYL), six months after rejecting Mylan’s application. Canonsburg, PA-based Mylan’s shares jumped 7% to $30.82 at market close after yesterday’s late-afternoon announcement, and were trading at $30.96 mid-morning today. GSK’s stock dipped 2% to$38.70 on the news late yesterday, but had more than […]
Teva launches generic EpiPen at the same price as existing device
Teva (NYSE:TEVA) this week launched its generic version of Mylan‘s (NSDQ:MYL) EpiPen auto-injector and announced that it would sell the emergency allergy therapy for $300 – the same price as Mylan’s own generic EpiPen product. The price for Teva’s product inspired some head-scratching among patient advocates and healthcare professionals. After all, when the FDA first approved Teva’s […]
EU approves fifth biosimilar for blockbuster Humira drug
Mylan (NSDQ:MYL) and Fujifilm Kyowa Kirin Biologics said today that the European Commission gave the companies marketing authorization for Hulio, a biosimilar to AbbVie‘s (NYSE:ABBV) billion-dollar Humira product. Mylan said it plans to launch Hulio across particular markets in Europe on or after Oct. 16. The drug is the fifth product authorized by the EC as a biosimilar for […]
Mylan launches generic Brevibloc heart injection
Mylan (NSDQ:MYL) said today that it launched a generic version of Baxter‘s (NYSE:BAX) Brevibloc heart drug in the U.S. The company’s injectable product, esmolol hydrochloride in sodium chloride, will be offered in single-dose plastic bags, according to Mylan. Get the full story at our sister site, Drug Delivery Business News.
FDA extends expiration date for swath of Mylan’s Epipens amid shortage
In an attempt to mitigate an ongoing shortage of Epipen auto-injectors, the FDA today extended the expiration date of specific lots of 0.3-mg devices by four months. The move to extend the expiration dates beyond the approved 20-month shelf-life is based on stability data provided by Mylan (NSDQ:MYL) to the FDA, the U.S. regulatory agency reported. Get the […]
FDA approves first generic Epipen
The FDA this week approved the first generic version of Mylan‘s (NSDQ:MYL) Epipen emergency allergy auto-injector. Teva Pharmaceuticals (NYSE:TEVA), which won the historic approval, plans to market the generic epinephrine auto-injector in 0.3mg and 0.15mg doses. There are other epinephrine auto-injectors on the market in the U.S., but Teva’s is the first that’s approved to directly substitute […]
In midst of Epipen shortage, Kaleo confirms ‘sufficient supply’ of Auvi-Q auto-injectors
Kaleo said today that despite ongoing manufacturing delays reported by epinephrine auto-injector manufacturers, Kaleo’s Auvi-Q device is available via prescription and that the privately-held company has ‘sufficient supply to meet any anticipated demand.’ Kaleo’s epinephrine auto-injector features voice instructions that guide users through the drug-delivery process and an auto-retractable needle system, according to the company. Get […]
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