Generic versions of major depression drug availableMylan received approval from FDA to market its desvenlafaxine extended-release tablets, the generic version of Pristiq (Pfizer), for major depressive disorder. Plus, 2 other manufacturers recently received approval for their generic versions of Pristiq.
Drug maker pays out millions over EpiPen chargesAs Mylan continues to face criticism over price hikes on its EpiPen epinephrine injection, the company agreed to a $465 million settlement with the U.S. Department of Justice and other agencies for overcharging on the EpiPen.
Cheaper generic EpiPen doesn't quiet criticsDespite offering a generic version of its EpiPen, Mylan has been unable to curb the backlash that began in late August over the cost of its epinephrine injection.
EpiPen discounts offered after pricing flapAfter protests by patients, parents and Congressional representatives, Mylan said it would offer discounts on its epinephrine EpiPen Auto-Injector treatment to stop allergic reactions.
A host of new generics launch in 2015A look at some of the year's launches from key manufacturers.
Teva’s Mylan bid set to shake up industryTeva Pharmaceutical’s unsolicited $40 billion offer to acquire Mylan N.V. is expected to shake up the pharmaceutical industry, especially in the areas of generic and specialty drugs. A Teva acquisition of Mylan would be the biggest health care deal of the year so far and the largest acquisition ever proposed by an Israeli company, according to S.&P. Capital IQ, The New York Times reported.
Hospira scores temporary win in lawsuit versus FDAPrecedex, dexmedetomidine hydrochloride, is approved to sedate patients with breathing tubes in an intensive-care setting, as well as patients without breathing tubes before and during surgeries and other procedures. Hospira’s patent that covers the use of Precedex in an intensive-care setting in due to expire in 2019, however other patents have already expired. On Monday, the FDA approved the sale of generic copies of the drug as long as the companies leave out information from the prescribing labels about uses that are covered under Hospira’s patent, including “intensive-care unit sedation.”
FDA drug approvals-August 2014FDA actions in brief, complete response, fast-track designation, priority review, orphan drug designations, first-time generic approval
Mylan donates $3 million for typhoon relief effortsIn its largest gift ever to AmeriCares, Mylan has donated more than $3 million in medicines to aid that organization’s Typhoon Haiyan relief efforts in the Philippines. The various medicines will be used to treat patients with infections, diabetes, and cardiovascular diseases.
FDA pipeline preview