Results for Mylan (62)

  News   Mylan Launches First Generic Version of Teveten Tablets
Mylan announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Eprosartan Mesylate Tablets, 400 mg (base) and 600 mg (base).
  News   Mylan Confirms First-to-File Patent Challenge Relating to FROVA Tablets
Mylan Inc. (Nasdaq: MYL) confirmed that the company and its subsidiary Mylan Pharmaceuticals Inc. have been sued by Endo Pharmaceuticals in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Frovatriptan Succinate EQ, 2.5 mg base tablets.
  News   Mylan Receives Approval for Generic Version of Effexor XR Capsules
Mylan Inc. 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 Venlafaxine Hydrochloride (HCl) Extended-release (ER) Capsules, 37.5 mg (base), 75 mg (base) and 150 mg (base), the generic version of Wyeth`s Effexor XR® Capsules, which are used in the treatment of major depressive disorder and social anxiety disorder.
  News   Mylan Receives Approval for Generic Version of Xalatan Ophthalmic Solution
Mylan Inc. 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 Latanoprost Ophthalmic Solution, 0.005%, the generic version of Pharmacia and Upjohn`s Xalatan® Ophthalmic Solution, an eyedrop that lowers pressure in the eye.
  News   Mylan Launches First Generic Version of Vfend Tablets
Mylan Inc. announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Voriconazole Tablets, 50 mg and 200 mg, under a previously announced settlement and license agreement with Pfizer Inc.
  News   Mylan Receives Approval for First-to-File Generic Sular Extended-Release Tablets
Mylan Inc. 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 Nisoldipine Extended-release (ER) Tablets, 8.5 mg, 17 mg, 25.5 mg and 34 mg.
  News   Mylan`s Matrix Receives Tentative FDA Approval Under PEPFAR for Lamivudine and Zidovudine Tablets, 30 mg/60 mg
Mylan Inc.announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President`s Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Lamivudine and Zidovudine Tablets, 30 mg/60 mg.
  News   Mylan Receives Approval for Generic Version of Adalat CC Tablets
Mylan 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 Nifedipine Extended-release Tablets USP, 30 mg, 60 mg and 90 mg, the generic version of Bayer`s Adalat® CC Tablets, a treatment for hypertension.
  News   Mylan`s Matrix Receives Tentative FDA Approval Under PEPFAR for Abacavir Sulfate Tablets, 60 mg
Mylan announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President`s Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Abacavir Sulfate Tablets, 60 mg.
  News   Mylan and Mylan Charitable Foundation Award a Collective $1.25 Million to Prominent West Virginia Cultural Institutions
Mylan Inc. announced that the company and Mylan Charitable Foundation have awarded a collective $1.25 million to support two prominent West Virginia cultural institutions - The Clay Center for the Arts and Sciences of West Virginia and the State of West Virginia Division of Culture and History.
  News   Mylan Schedules Third Quarter 2010 Financial Results Conference Call and Live Webcast
Mylan Inc. (Nasdaq: MYL) announced that it will host a conference call and live webcast on Tuesday, Oct. 26, 2010, at 5 p.m. ET, to review the company`s financial results for the third quarter 2010, which ended Sept. 30, 2010.
  News   Mylan Reports Adjusted Diluted EPS of $0.43; Reaffirms 2010 Adjusted Diluted EPS Guidance of $1.55 - $1.65
Mylan Inc. announced its financial results for the three and nine months ended September 30, 2010, and reaffirmed its 2010 adjusted diluted earnings per share (EPS) guidance of $1.55 - $1.65.
  News   Mylan Receives Approval for Generic Version of Mirapex(R) Tablets
Mylan Inc. 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 Pramipexole Dihydrochloride Tablets, 0.125 mg, 0.25 mg, 0.5 mg, 1 mg and 1.5 mg, the generic version of Boehringer Ingelheim`s Mirapex(R) Tablets, a Parkinson`s disease treatment.
  News   Mylan Announces Completion of Add-On Offering of Senior Notes
Mylan Inc. (Nasdaq: MYL) today announced that it has completed a private placement of $300 million aggregate principal amount of Senior Notes due 2020.
  News   Mylan Receives Approval for Generic Version of Catapres-TTS
Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Technologies Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Clonidine Transdermal System USP, 0.1 mg/day, 0.2 mg/day and 0.3 mg/day, the generic version of Boehringer Ingelheim`s Catapres-TTS, a treatment for hypertension.
  News   Mylan Launches the Generic Version of Solodyn(R), 45 mg, 90 mg and 135 mg Tablets, Announces Settlement Agreement with Medicis
Mylan Inc. (Nasdaq: MYL) announced that its subsidiary Matrix Laboratories Limited received final approval on July 20 from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Minocycline Hydrochloride Extended Release Tablets (Minocycline ER), 45 mg, 90 mg and 135 mg, the generic version of Solodyn(R) ER, a treatment for acne, sold by Medicis Pharmaceuticals Corporation (Medicis).
  News   Mylan Announces Settlement Agreement for Namenda
Mylan Inc. (Nasdaq: MYL) announced that it has entered into settlement and license agreements with Forest Laboratories and Merz Pharmaceuticals related to Namenda(R) Tablets, 5 mg and 10 mg, known generically as Memantine Hydrochloride (HCl) Tablets.
  News   Mylan to Acquire Bioniche Pharma Global Injectable Pharmaceuticals Business
Mylan Inc. (Nasdaq: MYL) announced plans to acquire Bioniche Pharma Holdings Limited, a privately held, global injectable pharmaceutical company for $550 million in cash.
  News   Mylan Receives Approval for Nabumetone Tablets
Mylan Inc. (Nasdaq: MYL) announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Nabumetone Tablets USP, 500 mg and 750 mg.
  News   Mylan Receives Approval for Generic Version of Procardia XL Tablets
PITTSBURGH, June 24, 2010 /PRNewswire via COMTEX News Network/ -- 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 Nifedipine Extended-release Tablets USP, 30 mg, 60 mg and 90 mg, the generic version of Pfizer`s Procardia XL(R) Tablets, a treatment for angina and/or hypertension.
  News   Mylan Receives Approval for Generic Version of Arimidex Tablets
PITTSBURGH, June 29, 2010 /PRNewswire via COMTEX News Network/ -- Mylan Inc. (Nasdaq: MYL) 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 Anastrozole Tablets, 1 mg, the generic version of AstraZeneca`s Arimidex(R) Tablets, a treatment for early breast cancer.
  News   Mylan Receives Approval for Hydroxyzine Hydrochloride Tablets
PITTSBURGH, June 17, 2010 /PRNewswire via COMTEX News Network/ -- Mylan Inc. (Nasdaq: MYL) announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Hydroxyzine Hydrochloride Tablets 10 mg, 25 mg and 50 mg.
  News   Mylan Receives Approval for Generic Version of Neurontin Tablets
PITTSBURGH, June 4, 2010 /PRNewswire via COMTEX News Network/ -- Mylan Inc. (Nasdaq: MYL) announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Gabapentin Tablets USP, 600 mg and 800 mg, the generic version of Pfizer`s Neurontin(R) Tablets for the treatment of postherpetic neuralgia, a complication of shingles.
  News   Mylan Introduces Online Resource Centre for Continuing Education of Canadian Pharmacists
June 2, 2010 (Toronto) – Mylan Pharmaceuticals ULC has launched the Mylan Learning Centre, an online portal designed to provide pharmacists with continuing education lessons and support their learning by offering added context, important information and much-valued training.
  News   Mylan Receives Approval for Generic Version of Valtrex
PITTSBURGH, May 26, 2010 /PRNewswire via COMTEX News Network/ -- Mylan Inc. (Nasdaq: MYL) announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Valacyclovir Hydrochloride Tablets, 500 mg (base) and 1000 mg (base), the generic version of GlaxoSmithKline`s Valtrex(R), a treatment for the herpes virus infection.

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