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 […]
Mylan launches generic drug-delivery patch for dementia patients
Mylan (NSDQ:MYL) announced today the U.S. launch of its rivastigmine transdermal drug-delivery patch, a generic version of Novartis‘ (NYSE:NVS) Exelon therapy. The company’s rivastigmine therapy is indicated for the treatment of dementia associated with Alzheimer’s disease and Parkinson’s disease. Get the full story at our sister site, Drug Delivery Business News.
FDA approves first generic sublingual film to treat opioid addiction
The FDA this week approved the first generic version of Indivior‘s (LON:INDV) billion-dollar opioid addiction treatment, Suboxone. The generic buprenorphine and naloxone sublingual film, sold by Dr. Reddy’s Laboratories (NYSE:RDY) and Mylan (NSDQ:MYL), is designed to suppress withdrawal symptoms that crop in people addicted to opioids, as well as block the neurochemical effects of opioids. Get the […]
FDA rejects Mylan’s Advair generic in win for GSK
Shares in Mylan (NSDQ:MYL) dropped -5% yesterday after the pharmaceutical company revealed that it received the dreaded ‘complete response letter’ from the FDA, denying its application for a generic version of GlaxoSmithKline‘s (NYSE:GSK) blockbuster Advair respiratory drug. Canonsburg, PA-based Mylan noted that the CRL was due to “minor deficiencies” identified in its application and that it expects […]
Tribe taking steps to ‘ramp up’ drug patent business
The Native American tribe wrapped up in litigation with generic pharmaceutical companies is trying to prove that its arrangement with Allergan (NYSE:AGN) reflects a legitimate move to boost its economy, according to court documents. The St. Regis Mohawk Tribe of New York found itself it the middle of a controversial deal this year after it agreed to […]
Mylan misses estimates on The Street with Q1 results
Shares in Mylan (NSDQ:MYL) rose slightly this morning after the pharmaceutical company reported its first-quarter financial results, missing analysts’ sales and earnings estimates. The company posted profits of $87.1 million, or 17¢ per share, on sales of $2.68 billion for the 3 months ended March 31, for bottom-line growth of 31% on sales loss of -1% compared […]
Manufacturing delays lead to Epipen shortage in U.S.
At least 400 people across the U.S. have had trouble getting their hands on an Epipen in recent weeks, according to a survey from the advocacy group Food Allergy Research & Education. Mylan (NSDQ:MYL), which makes the emergency allergy auto-injector, reportedly told the FDA months ago that manufacturing delays were straining its Epipen supply. Get the […]
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