Mylan has received tentative approval from the U.S. Food and Drug Administration (FDA) for its New Drug Applications (NDAs) for two dosages of abacavir/lamivudine tablets for oral suspension for the treatment of HIV-1 infection in pediatric patients.
Mylan has entered into an agreement with Gilead Sciences under which Mylan has licensed the non-...
Mylan has confirmed that it and several subsidiaries have been sued by several Baxter...
Some lots of the product, called Mylan-Nitro Sublingual Spray 0.4 mg Per Metered Dose, are potentially missing the dip tube, a part of the pump component. A missing dip tube could pose a problem with delivery of nitroglycerin to the patient.
Mylan today announced it is initiating Phase III clinical trials for its generic version of GlaxoSmithKline's Advair Diskus and its insulin analog to Sanofi's Lantus. In October 2014, Mylan will commence a Phase III clinical trial to evaluate the equivalence of its product to Advair Diskus when administered by inhalation in adult asthma patients.
Mylan has entered into an agreement to acquire the U.S. commercialization, marketing and intellectual property rights relating to Arixtra® (fondaparinux sodium) Injection and the authorized generic (AG) of Arixtra from Aspen Global Incorporated.
Mylan reported profit that declined by 30 percent in its second quarter, and missed analysts' expectations. The Canonsburg, Pennsylvania-based company said net income fell to $125.2 million, or 32 cents per share, from $177.7 million, or 46 cents per share.
Mylan said Monday that the deal will diversify and expand its business outside the U.S. The combined company will be organized in the Netherlands, which will help reduce its tax expenses, while maintaining its headquarters near Pittsburgh.
Mylan's first-quarter net income rose about 8 percent, and the generic drugmaker said Thursday that it is still hunting for acquisitions and it expects to pull off a "substantial transaction" this year.
Swedish pharmaceutical company Meda says it has rejected another offer from U.S. generic drugmaker Mylan Inc. Meda says its board decided to reject a revised Mylan proposal because the deal lacks support from Meda's largest shareholder, which the company did not name in a brief statement.
Mylan has launched XULANET, the generic version of Janssen Pharmaceuticals Inc.'s ORTHO EVRA (Norelgestromin / Ethinyl Estradiol Transdermal System 150/35 mcg per day).
PSX1001 and PSX1050, which are the first products to emerge from Prosonix's innovative and proprietary particle engineering platform, are being developed as generic versions to GlaxoSmithKline's pressurized metered dose inhalers (pMDI) Flixotide® and Flovent®, respectively.
Swedish drug company Meda has rebuffed an approach from generic drug maker Mylan which was looking to combine the two businesses. Meda AB says talks between the two companies have stopped "without further actions."
The justices agreed Monday to hear an appeal from Teva Pharmaceutical Industries Ltd., which claims the U.S. Court of Appeals for the Federal Circuit wrongly overturned five of its patents for the drug Copaxone.
Mylan has announced that, after a trial in the United States District Court for the District of New Jersey, a jury returned a verdict in favor of Mylan in its breach of contract lawsuit against GSK relating to Paroxetine Hydrochloride Extended-release (ER) Tablets.
Mylan Inc. has announced the United States District Court for the Northern District of West Virginia issued a decision upholding the validity of all patents asserted by Mylan, protecting Perforomist (formoterol fumarate) Inhalation Solution.
Shares of Mylan Inc. jumped in premarket trading Thursday as the generic drugmaker reported an 11 percent increase in its fourth-quarter earnings, topping expectations despite a rise in expenses.
Mylan has announced that its subsidiary Agila Specialties Private Limited is conducting a voluntary nationwide recall to the hospital/user level of 10 lots of Etomidate Injection 2 mg/mL - 10 mL and 20 mL.
Mylan Inc. has announced that its India-based subsidiary Mylan Pharmaceuticals Private Limited has been named Gilead Sciences, Inc.'s exclusive branded medicines business partner for India.
Bamzai has more than 20 years of experience in the Indian and global biopharmaceutical industry. Prior to joining Mylan, he was president of Marketing at Biocon, where he played a key role in building the company's global biopharmaceutical business.
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 issued a favorable ruling in the company’s patent infringement lawsuit against Mylan regarding an AZILECT ® (rasagiline tablets) patent which covers methods of treating Parkinson’s disease (PD).
Mylan Inc. has announced the completion of an 85,000 square foot, three-story expansion project at its transdermal patch facility, operated by Mylan Technologies Inc. (MTI), in St. Albans, Vt.
Shares of Mylan Inc. climbed to an all-time high Friday after the generic drugmaker's outlook over the next five years pleased investors. Mylan expects net income to reach at least $6 per share in 2018, more than double its estimate for 2013, and projects revenue growth of about 13 percent per year through 2018.
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...
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