All Releases
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Mylan Receives Tentative FDA Approval for Generic Version of Lipitor®
Feb 2, 2012
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PITTSBURGH, Feb. 2, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Laboratories Limited (formerly Matrix Laboratories Limited) has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Atorvastatin Calcium Tablets, 10 mg (base), 20 mg...
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Mylan to Host Investor Day on Feb. 21, 2012, in New York City
Jan 24, 2012
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NEW YORK, Jan. 24, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) will host an Investor Day on Feb. 21, in New York City. Robert J. Coury, Mylan's executive chairman; Heather Bresch, chief executive officer; Rajiv Malik, president; Hal Korman, chief operating officer; John Sheehan, chief financial officer; and John Thievon, president of Dey Pharma...
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Mylan Launches Innovative Version of Antiepileptic Drug Levetiracetam
Jan 19, 2012
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PITTSBURGH, Jan. 19, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its Mylan Institutional business has launched Levetiracetam in Sodium Chloride Injection, 500 mg/100 mL, 1000 mg/100 mL and 1500 mg/100 mL, for intravenous use. Mylan's launch of this new product, which has been approved by the U.S. Food and Drug Administration ...
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Mylan Confirms First-to-File Patent Challenge Relating to Actoplus Met® XR Tablets
Jan 9, 2012
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PITTSBURGH, Jan. 9, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today confirmed that the company has been sued by Takeda Pharmaceutical Company, Watson Pharmaceuticals and Andrx Labs in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Pioglitazone Hydrochloride and Exten...
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Mylan Launches First Generic Version of Teveten® Tablets
Dec 27, 2011
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PITTSBURGH, Dec. 27, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Eprosartan Mesylate Tablets, 400 mg (base) and 600 mg (base). This product is the generic v...
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Mylan Receives Approval for First-to-File Generic Keppra XR® Extended-Release Tablets
Dec 27, 2011
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PITTSBURGH, Dec. 27, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam Extended-release (ER) Tablets, 500 mg and 750 mg. This product is the generic...
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Mylan Receives WHO Approval for Innovative 'Second-Line-in-a-Box' HIV/AIDS Treatment
Dec 20, 2011
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PITTSBURGH, Dec. 20, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Laboratories Limited (formerly Matrix Laboratories Limited) has received approval for three antiretroviral (ARV) therapies used to treat HIV/AIDS under the World Health Organization's (WHO) Prequalification of Medicines Programme. The produc...
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Mylan Launches Generic Version of Toprol-XL® Tablets
Dec 16, 2011
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PITTSBURGH, Dec. 16, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Metoprolol Succinate Extended-release (ER) Tablets USP, 25 mg, 50 mg, 100 mg, and 200 mg. T...
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Mylan Names John Thievon President of Dey Pharma
Dec 12, 2011
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PITTSBURGH, Dec. 12, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced the appointment of John Thievon as president of Dey Pharma, L.P., Mylan's fully integrated specialty pharmaceutical business.
Thievon has more than 20 years of professional experience in strategic product launches, marketing, commercialization, sales penetrat...
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Mylan Launches Generic Version of Cyklokapron® Injection
Dec 2, 2011
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PITTSBURGH, Dec. 2, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its business Mylan Institutional has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Tranexamic Acid Injection, 100 mg/mL, packaged in 1,000 mg/10 mL Single-dose Vials. This product is t...
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Mylan Receives Tentative FDA Approval Through PEPFAR for First Heat-Stable, Fixed-Dose Combination of Atazanavir Sulfate and Ritonavir Tablets for HIV/AIDS
Dec 1, 2011
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PITTSBURGH, Dec. 1, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Laboratories Limited (formerly Matrix Laboratories Limited) has received tentative approval from the U.S. Food and Drug Administration (FDA) through the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) fo...
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Mylan Confirms First-to-File Patent Challenge Relating to Generess™ Fe
Dec 1, 2011
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PITTSBURGH, Dec. 1, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today confirmed that it and Famy Care Ltd. have been sued by Warner Chilcott Company LLP, in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Norethindrone and Ethinyl Estradiol Chewable Tablets, 0.8 mg/0.02...
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Mylan Launches Generic Version of Caduet® Tablets
Dec 1, 2011
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PITTSBURGH, Dec. 1, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Amlodipine Besylate and Atorvastatin Calcium Tablets, 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg, the gener...
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Mylan Committed to Expanding Access in Developing Countries to High Quality, Affordable HIV/AIDS Treatment
Dec 1, 2011
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PITTSBURGH, Dec. 1, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today affirmed its commitment to expand the access of people living with HIV/AIDS in the developing world to high quality, affordable treatment. The company is the proud sponsor of a special World AIDS Day exhibition and reception today in Washington D.C. The event is hosted by the W...
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Mylan Receives Approval for Generic Version of Zinecard® for Injection
Nov 28, 2011
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PITTSBURGH, Nov. 28, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its business Mylan Institutional has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Dexrazoxane for Injection, packaged in 250 mg and 500 mg Single-use Vials. This product is the gener...
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Mylan Announces Settlement Agreement for its First-to-File Generic Version of Vivelle-Dot®
Nov 21, 2011
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PITTSBURGH, Nov. 21, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that it has settled a patent litigation lawsuit with Novartis Pharmaceuticals Corporation related to Vivelle-Dot® (Estradiol Transdermal System USP, Twice-Weekly, 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day and 0.075 mg/day and 0.1 mg/day).
Pursuant to the ...
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Mylan Successfully Upsizes and Completes Refinancing of Credit Facility
Nov 14, 2011
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PITTSBURGH, Nov. 14, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that it has successfully completed the previously announced refinancing of its existing secured credit facility. The company's new $2.5 billion senior secured credit facility was upsized from the originally planned $2.25 billion and comprises a $1.25 billion revolvin...
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Mylan Applauds Obama Administration's Call to Create an "AIDS-Free Generation" Through Global Fight Against HIV/AIDS
Nov 9, 2011
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PITTSBURGH, Nov. 9, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today applauded the Obama administration's call to action in the global fight against HIV/AIDS.
Mylan President Heather Bresch commented: "While the generics industry has made significant contributions toward making HIV/AIDS medicines more affordable, we believe the focus must now...
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Mylan to Acquire Pfizer Respiratory Delivery Platform
Nov 9, 2011
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PITTSBURGH, Nov. 9, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that it has entered into an agreement with Pfizer for the exclusive worldwide rights to develop, manufacture and commercialize Pfizer's generic equivalent to GlaxoSmithKline's Advair® Diskus and Seretide® Diskus incorporating Pfizer's proprietary dry powder ...
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Mylan Receives Approval for Generic Version of MS Contin® Tablets
Oct 27, 2011
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PITTSBURGH, Oct. 27, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Morphine Sulfate Extended-release (ER) Tablets, 15 mg, 30 mg, 60 mg, 100 mg and 200 mg, the...
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