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Valeant Says Generic Approval Could Lower Profit
April 4, 2013 9:58 am | by The Associated Press | News | CommentsValeant Pharmaceuticals International Inc. said Thursday that a newly approved generic version of one of its drugs could significantly reduce its profits this year. Mylan Inc. on Wednesday received final approval from the U.S. Food and Drug Administration to sell the first generic version of...
Mylan Announces Fortamet Settlement Agreement
March 14, 2013 8:08 am | News | CommentsMylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has entered into a settlement agreement with Shionogi Inc. and Andrx that will resolve patent litigation related to Metformin Hydrochloride Extended-release Tablets USP, 500 mg and 1000 mg. This product is the generic version of Shionogi's Fortamet.
Mylan to Buy Agila of India for $1.6B
February 27, 2013 6:08 pm | by The Associated Press | News | CommentsGeneric drug maker Mylan Inc. said it will buy Agila Specialties for $1.6 billion in cash, expanding its offerings of injectable drugs and its sales in international markets. Mylan, currently the fourth-largest maker of generic drugs in the world, is buying Agila from Strides Arcolab. It could...
Mylan to Help Market Biocon's Generic Insulin Drugs
February 13, 2013 6:14 pm | by The Associated Press | News | CommentsMylan Inc. said Wednesday it will help market generic versions of some of the biggest-selling insulin drugs in the world under a new agreement with Biocon Ltd., India's largest biotechnology company by revenue. The companies did not disclose terms of the deal. Mylan said it will have the right...
Mylan Settles Litigation Relating to Detrol LA
September 7, 2012 3:50 am | News | CommentsMylan Inc. today announced that it and its subsidiary, Mylan Pharmaceuticals Inc., have entered into a settlement agreement with Pfizer Inc., Pharmacia & Upjohn Company LLC and Pfizer Health AB that will resolve the parties' patent litigation in connection with Mylan Pharmaceuticals' Abbreviated New Drug Application (ANDA) for Tolterodine Tartrate ER capsules.
Pfizer and Mylan to Collaborate on Generics Business in Japan
August 23, 2012 4:00 am | News | CommentsPfizer Inc. and Mylan Inc. today announced that they have signed a definitive agreement to establish an exclusive long-term strategic collaboration to develop, manufacture, distribute and market generic drugs in Japan
Mylan Launches Generic Version of Provigil Tablets
August 10, 2012 4:01 am | News | CommentsMylan Inc. today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Modafinil Tablets USP,100 mg and 200 mg.
Mylan Subsidiary Starts Operations in India(2)
August 6, 2012 4:17 am | News | CommentsPITTSBURGH (AP) —Mylan Inc. says a subsidiary has started commercial operations in India, beginning with products that treat HIV and AIDS.
Mylan Confirms First-to-File Patent Challenge Relating to Pristiq Tablets
June 28, 2012 4:07 am | News | CommentsMylan Inc. today confirmed that the company has been sued by Pfizer Inc., Wyeth LLC, Wyeth Pharmaceuticals Inc., and PF Prism C.V. in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Desvenlafaxine Succinate Extended-release Tablets, 50 mg and 100 mg.
Generics Impact Forest Labs Profits
June 11, 2012 6:25 am | by Associated Press | News | CommentsForest Laboratories, Inc. slashed its fiscal-year profit outlook, pointing to stiff generic competition for its blockbuster anti-depressant Lexapro.
Mylan Settles Provigil Litigation With Teva
June 8, 2012 4:11 am | News | CommentsMylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has resolved all disputes with Teva Pharmaceuticals USA, Inc. stemming from litigation brought by Mylan in federal court in the District of Columbia against the U.S. Food and Drug Administration (FDA) concerning Mylan's abbreviated new drug application (ANDA) for Modafinil Tablets, 100 mg and 200 mg.
Mylan Announces Settlement Agreement in Litigation Relating to its Generic Xopenex
May 29, 2012 4:30 am | News | CommentsMylan Inc. today announced that Mylan Specialty L.P., f/k/a Dey Pharma, L.P., has entered into a settlement agreement with Sunovion Pharmaceuticals Inc., f/k/a Sepracor Inc., that will resolve the parties' patent litigation in connection with Mylan Specialty's Abbreviated New Drug Application (ANDA) for Levalbuterol Hydrochloride (HCl) Inhalation Solution .
Moody's Raises Mylan Credit Rating One Notch
May 24, 2012 8:15 am | News | CommentsNEW YORK (AP) — Moody's Investors Service raised its credit rating on Mylan Inc. Wednesday, saying it expects strong sales growth for the generic drugmaker.
Mylan Launches Generic Doryx At 150 MG
May 1, 2012 6:45 am | News | CommentsMylan, Inc. today announced that its subsidiary Mylan Pharmaceuticals, Inc. has launched Doxycycline Hyclate Delayed-release (DR) Tablets USP, 150 mg, following a favorable decision by the U.S. District Court for the District of New Jersey in a patent infringement lawsuit brought by Warner Chilcott.
Teva, Mylan Settle Litigation over Nuvigil
April 30, 2012 6:13 am | by the Associated Press | News | CommentsIsraeli drugmaker Teva Pharmaceutical Industries Ltd. said Monday that it has settled patent infringement litigation over Nuvigil and will allow rival generic drugmaker Mylan Inc. to sell generic versions of the sleep-disorder drug.
Mylan and Pfizer Announce Epinephrine Auto-injector Settlement Agreement with Teva
April 26, 2012 4:02 am | News | CommentsMylan Inc. and Pfizer Inc. today announced that Meridian Medical Technologies, a Pfizer subsidiary, has entered into a settlement agreement with Teva that will resolve pending patent litigation related to its abbreviated new drug application (ANDA) for a generic epinephrine auto-injector.
Mylan Receives FDA Approval for Generic Zyprexa(2)
April 24, 2012 4:00 am | News | CommentsCANONSBURG, Pa. (AP) — Mylan Inc. has become the latest drugmaker to receive approval for a generic version of Eli Lilly and Co.'s blockbuster antipsychotic Zyprexa.
Mylan Announces Expansion in Ireland
April 18, 2012 4:08 am | News | CommentsMylan will add more than 500 new positions to its Ireland-based workforce by 2016. Mylan currently is the largest generics pharmaceutical manufacturer in Ireland and one of the world's leading pharmaceutical companies.
Mylan Launches First Generic Version of Lescol Capsules
April 13, 2012 4:08 am | News | CommentsMylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for Fluvastatin Capsules USP, 20 mg and 40 mg, the first generic version of Novartis' Lescol Capsules.
Mylan Sues FDA Seeking Ruling That Teva Holds No Exclusivity for Its Generic Version of Provigil
April 6, 2012 4:15 am | News | CommentsMylan Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., has filed suit against the U.S. Food and Drug Administration (FDA) in the U.S. District Court for the District of Columbia seeking to overturn a decision by FDA, which awarded Teva sole 180-day exclusivity for the generic version of its affiliate Cephalon's Provigil.
Mylan Launches Generic Version of Mesnex Injection
April 3, 2012 3:59 am | News | CommentsMylan Inc. today announced that its Mylan Institutional business has launched Mesna Injection, 100 mg/mL, packaged in 1,000 mg/10mL multiple-dose vials.
Mylan Launches Generic Version of Seroquel Tablets, 25 mg
March 28, 2012 4:05 am | News | CommentsMylan Inc. 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 Quetiapine Fumarate Tablets, 25 mg.
Mylan to Build New Corporate Headquarters
March 12, 2012 3:56 am | News | CommentsMylan Inc. plans to build a new corporate headquarters near its current location in the Southpointe Office Park located in Cecil Township, Washington County, Pa., just south of Pittsburgh.
Mylan Launches First Equivalent Product to Lexapro Tablets
February 29, 2012 2:53 am | News | CommentsMylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Escitalopram Tablets USP, 5 mg, 10 mg and 20 mg, the first equivalent product to Forest Laboratories' Lexapro, which is used for acute and maintenance treatment of major depressive disorder (MDD) and acute treatment of generalized anxiety disorder (GAD).
Mylan Receives Tentative FDA Approval for Pediatric HIV and AIDS Therapy
February 23, 2012 3:02 am | News | CommentsMylan Inc. 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) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Abacavir Sulfate and Lamivudine Tablets, 60 mg/30 mg.
