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US Patent Office Rules Sanofi's Formulation Patents on Multibillion-Dollar Lantus Invalid
americanpharmaceuticalreview
December 14, 2018
Mylan announced the U.S. Patent and Trademark Appeal Board (PTAB) has ruled in favor of Mylan in its inter partes review (IPR) proceedings and .....
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Generics 'cartel' probe expands to a whopping 300 drugs: report
fiercepharma
December 11, 2018
Years into a government probe over alleged generic drug price fixing, investigators have expanded the scope to include 300 drugs and 16 companies, an official told The Washington Post.
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Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets
americanpharmaceuticalreview
December 10, 2018
Mylan N.V. announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of .....
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Mylan recalls all lots of blood pressure drugs containing valsartan
pharmaceutical-technology
December 10, 2018
Mylan has expanded the consumer-level voluntary recall of all lots of valsartan-containing drugs within expiry in the US after finding trace amounts of an impurity called N-nitrosodiethylamine (NDEA).....
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Valsartan recall expands to Mylan, Teva products
fiercepharma
December 06, 2018
When a suspected carcinogen was detected by a U.S. drugmaker last summer in the API it had acquired to make blood pressure drugs, it first appeared to be another issue of tainted products produced in China. Since then
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Mylan Launches Generic for Prevacid SoluTab Delayed-Release ODT
americanpharmaceuticalreview
December 05, 2018
Mylan announced the U.S. launch of Lansoprazole Delayed-Release (DR) Orally Disintegrating Tablets (ODT), 15 mg and 30 mg, a generic version of Takeda's Prevacid SoluTab DR ODT....
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Teva prices generic EpiPen at parity with Mylan's generic version
firstwordpharma
November 28, 2018
Teva said Tuesday that its generic version of Mylan's EpiPen (epinephrine) will carry a wholesale acquisition cost of $300 in the US. The Israeli drugmaker's product gained FDA approval in August as the first generic version of the auto-injector for the e
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FDA tags Mylan West Virginia plant with warning letter
fiercepharma
November 26, 2018
The other shoe has finally dropped on Mylan’s troubled manufacturing plant in West Virginia. The drugmaker acknowledged Tuesday that the FDA this month issued a warning letter for the problems at the massive site.
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Mylan West Virginia plant tagged with warning letter by FDA
fiercepharma
November 21, 2018
The other shoe has finally dropped on Mylan’s troubled manufacturing plant in West Virginia. The drugmaker acknowledged Tuesday that the FDA this month issued a warning letter for the problems at the massive site.
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UK launch for Mylan, Biocon insulin glargine biosimilar Semglee
pharmatimes
November 19, 2018
Mylan and Biocon have announced the UK launch of Semglee - an approved biosimilar of reference medicine insulin glargine.