Mylan and Biocon announced last week that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Ogivri, a biosimilar to Roche’s Herceptin (trastuzumab). The positive CHMP opinion is based on data submitted as part of the Marketing Authorization Application which included similarity assessment in analytical…
Mylan, Fujifilm Kyowa Kirin Biologics Receive Positive CHMP Opinion For Hulio
Mylan and Fujifilm Kyowa Kirin Biologics announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the Marketing Authorization Application of Hulio, the companies’ biosimilar to Humira (adalimumab), for all indications. The decision of the European Commission (EC) on the approval is expected in October 2018, which…
Mylan Launches Generic Angiomax Injection
Mylan has announced the U.S. launch of Bivalirudin for Injection, 250 mg single-dose vial, a generic version of Angiomax from The Medicines Company. The product is a direct thrombin inhibitor indicated for use as an anticoagulant in patients. Mylan is offering Bivalirudin for Injection, 250 mg single-dose vial, to its hospital and institutional customers after an Abbreviated New…
Mylan Launches Generic For Oral Contraceptive Yaz
Today, Mylan N.V. announced the U.S. launch of Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.02 mg, a generic version of Bayer’s Yaz Tablets. Mylan Pharmaceuticals received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for use by women to prevent pregnancy and for the treatment of…
Mylan To Leverage Scientific Platform To Develop Novel Delivery For Non-Opioid Pain Medication
Mylan has acquired global development and marketing rights from Prayog Labs LLC to bring to market a fast-acting Meloxicam as a proposed non-narcotic analgesic. This novel delivery has the potential to provide a non-addictive treatment option for acute pain that patients may experience, for example, during dentistry procedures, post-surgery, and with orthopedic defects. Meloxicam also…
Mylan Partners With Fujifilm Kyowa Kirin Biologics To Commercialize Biosimilar
Mylan is partnering with Fujifilm Kyowa Kirin Biologics to commercialize a biosimilar to Humira (adalimumab) developed by Fujifilm Kyowa Kirin Biologics. Through the partnership agreement, Mylan will leverage its regulatory platform to seek approval and commercialize the product in Europe. Humira is a TNF-inhibitor aimed at treating multiple chronic inflammatory conditions. The product is indicated in Europe for the treatment of…
Mylan Introduces Symfi HIV Treatment In The U.S.
Mylan N.V. will introduce in the U.S. a third cost-saving HIV combination. The FDA approved Symfi (efavirenz, lamivudine and tenofovir disoproxil fumarate) 600 mg/300 mg/300 mg tablets, a once-daily, single-tablet regimen (STR), indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least…
Mylan Launches Generic Mutamycin Injection, Adds To Growing Oncology Portfolio
Mylan launched the oncology drug Mitomycin for Injection USP, 5 mg/vial, 20 mg/vial and 40 mg/vial Single Dose Vials, a generic version of the reference listed drug, Bristol Myers Squibb’s Mutamycin in the U.S. market to be used in combination with other cancer medicines in the treatment of stomach and pancreatic cancers. Mylan is offering Mitomycin for…
Mylan In Collaboration To Develop Botox Biosimilar
Mylan and Revance Therapeutics, Inc. announced a global collaboration and license agreement for the development and commercialization of a proposed biosimilar to Botox (onabotulinumtoxinA). Botox is a neuromodulator approved for the treatment of multiple indications and usage in the United States with additional approvals globally. “Bringing an affordable biosimilar version of Botox to commercialization will offer patients a safe…
Mylan Receives Tentative Approval For Combination HIV Treatment
Mylan receives tentative approval for combination HIV treatment DTG/FTC/TAF under FDA’s PEPFAR program. Global pharmaceutical company Mylan N.V. received tentative approval from the U.S. Food and Drug Administration (FDA) under the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) for its new drug application for dolutegravir, emtricitabine, and tenofovir alafenamide tablets, 50 mg/200 mg/25 mg. The…
Mylan And Theravance NDA Okayed For Adults With COPD
Theravance Biopharma and Mylan Announce FDA Acceptance of New Drug Application for Revefenacin (TD-4208) in Adults with Chronic Obstructive Pulmonary Disease Theravance Biopharma, Inc. and Mylan N.V. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the companies’ recently submitted New Drug Application (NDA) for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist (LAMA). If…
Mylan Receives FDA OK For Generic Version Of Allergan’s Esterase Vaginal Cream
Mylan adds to U.S. women’s healthcare portfolio with FDA approval of first generic for Esterase cream. Mylan N.V. on Friday announced the U.S. launch of Estradiol Vaginal Cream USP, 0.01%, the first generic version of Allergan’s Estrace Cream. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA)…
