Mylan has announced that its partner Biocon has received approval for a Mylan-Biocon trastuzumab product from the Drug Controller General of India. This is the first regulatory approval for a Mylan-Biocon developed biosimilar product. The product is a biosimilar to Roche's Herceptin, indicated for the treatment of HER2 overexpressing breast cancer.
Teva Pharmaceutical today announced the U.S. District Court for the District of New Jersey has...
Mylan Inc. has announced the completion of an 85,000 square foot, three-story expansion project...
Mylan Inc.'s second-quarter earnings jumped 28 percent, as a drop in expenses helped the generic drugmaker counter sluggish revenue growth. The Canonsburg, Pa., company said Thursday it earned $177.7 million, or 46 cents per share, in the three months that ended June 30. That compares to earnings of $138.6 million, or 33 cents per share, in last year's quarter.
Mylan Inc., today announced that its subsidiary, Mylan Pharmaceuticals Private Limited, has launched a portfolio of Women's Care products in India. The portfolio, which initially will consist of eight products, focuses on therapies such as hormones, pre- and post-natal nutrition and management of premenstrual syndrome (PMS).
Mylan Inc. today announced the appointment of Roger Graham as president of Mylan Specialty. Graham will report to Tony Mauro, president of Mylan North America. Graham joins Mylan from Advandx, a private developer of in-vitro diagnostic tests in the infectious disease space. He was the company's chief commercial officer and developed its growth strategy for the U.S. and European markets.
Valeant 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 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.
Generic 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 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 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 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 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.
PITTSBURGH (AP) —Mylan Inc. says a subsidiary has started commercial operations in India, beginning with products that treat HIV and AIDS.
Mylan 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.
Forest Laboratories, Inc. slashed its fiscal-year profit outlook, pointing to stiff generic competition for its blockbuster anti-depressant Lexapro.
Mylan 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 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 .
NEW 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, 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.
Israeli 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 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.
CANONSBURG, 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 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 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 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 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 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.
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