Anticipated Availability of First-Time Generics - the enhanced site ...
Anticipated Availability of First-Time Generics - the enhanced site ...
Oct 3, 2017 ... ―To help explain the benefits of generic drugs to your patients, the FDA has patient education materials available at ... Branda. (Manufacturer). Generic Name . Generic Manufacturer(s)b,1. Anticipated Availabilityc. Asacol HD. (Apil). Mesalamine delayed-release tablet. 800 mg ..... Naproxen/Esomeprazole.

Hospira has approximately 19,000 employees globally and owns five manufacturing facilities in the US and 11 facilities outside the US. The subsidiary specialises in intravenously administered generic drugs, infusion therapies and clinical nutrition products, as well as the medical devices for administering these products. This was despite the divestment of certain products, including branded and generic injectables, and branded products distributed in South Africa to Litha Pharma, a wholly-owned subsidiary of Endo International, in October. Some of the major products launched by Hospira in 2015 include Remsima (infliximab), the first biosimilar monoclonal antibody approved for use in Brazil, and Bivalirudin for injection, a generic version of The Medicines Company’s Angiomax anticoagulant drug. Resources and information to help prescribe, dispense and take medicine with confidence.

Teva Pharmaceutical Industries is the world’s biggest generic drug manufacturing company based on 2015 revenue. Combined sales from the US and Indian markets accounted for more than half of Lupin’s total sales in 2015. We use them to give you the best experience. The company also received US FDA approval for the world’s first paediatric Lopinavir and ritonavir (LPV/r) 40mg/10mg oral pellets for treatment of AIDS in June that year. Its leading product is Tribuss, a once-a-day fixed-dose triple combination ARV launched in December 2011.

Sofosbuvir is indicated for treatment of hepatitis C, and Ledipasvir-Sofosbuvir is to treat chronic hepatitis C genotype 1 patients. Precedex Injection, another of a number of key approvals that had been pending with FDA, represents an important addition to Mylan's injectables portfolio and growing line of products in the anesthesia and pain management category. Some of the major product launches made by the company during 2015 include Nevirapine Extended-Release Tablets, 100mg, the generic version of Boehringer Ingelheim’s Viramune XR for treatment of HIV-1 infection, and Paliperidone Extended-Release Tablets, the generic version of Janssen’s Invega for treatment of schizophrenia, and a few generic contraceptive drugs. Novartis’s generic medicines division Sandoz operates under three segments: Retail Generics, Biopharmaceuticals and Oncology Injectables, and Anti-Infectives. PD’s leading products include Amloc, the top-selling anti-hypertensive drug Fedaloc, its Nifedipine, and Lancap, the best-selling lansoprazole. The year’s major highlight was the announcement to acquire 100% stake in the generic businesses InvaGen Pharmaceutical, and Exelan Pharmaceuticals. The company’s US generics sales in 2015 increased by 8% primarily due to the launch of Esomeprazole (the generic equivalent of Nexium) delayed-release capsules for reduction of stomach acids, and Aripiprazole (the generic equivalent of Abilify) tablets for treatment of schizophrenia. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. In December 2015, Fresenius Kabi doubled production capacity of its infusion solutions plant in Vilassar de Dalt, Spain. By clicking “Continue” below, you are leaving this Mylan affiliate site to arrive on a third-party site that is solely responsible for its content.



Drugs@FDA: FDA Approved Drug Products
Recent New and Generic Drug Approvals. This report displays ... For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA. 7 Day Report; 14 Day ... Hydrochloride ANDA #206798, Dexmedetomidine Hydrochloride, Injectable; Injection, ORIG-1, Zydus Pharms Usa Inc, Approved ... Precedex generic launch of nexium Mylan Launches Generic Precedex™ Injection - Another Key ... - NewsAug 19, 2014 ... 19, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) announced that its business Mylan Institutional has launched Dexmedetomidine Hydrochloride Injection, 100 mcg (base)/mL, packaged in 200 mcg (base)/2 mL Single-dose Vials, which is therapeutically equivalent to Hospira's Precedex™. Mylan ...

As we continue to bring a high quality, reliable supply of injectable products to the U. Zarxio (Zarzio outside the US) stimulates white blood cell production in cancer patients undergoing chemotherapy, and is the first biosimilar approved by the US Food and Drug Administration (FDA) and first to be launched in the country. Some of the major products launched by Hospira in 2015 include Remsima (infliximab), the first biosimilar monoclonal antibody approved for use in Brazil, and Bivalirudin for injection, a generic version of The Medicines Company’s Angiomax anticoagulant drug. Expected to close in 2016, the deal will enable the combined generic business to have a commercial presence across 100 markets and achieve a top three leadership position in more than 40 segments. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing Mylan is a global pharmaceutical company committed to setting new standards in health care.

The year’s major highlight was the announcement to acquire 100% stake in the generic businesses InvaGen Pharmaceutical, and Exelan Pharmaceuticals. Combined sales from the US and Indian markets accounted for more than half of Lupin’s total sales in 2015. The company’s US generics sales in 2015 increased by 8% primarily due to the launch of Esomeprazole (the generic equivalent of Nexium) delayed-release capsules for reduction of stomach acids, and Aripiprazole (the generic equivalent of Abilify) tablets for treatment of schizophrenia. Some of the major product launches made by the company during 2015 include Nevirapine Extended-Release Tablets, 100mg, the generic version of Boehringer Ingelheim’s Viramune XR for treatment of HIV-1 infection, and Paliperidone Extended-Release Tablets, the generic version of Janssen’s Invega for treatment of schizophrenia, and a few generic contraceptive drugs. PD’s leading products include Amloc, the top-selling anti-hypertensive drug Fedaloc, its Nifedipine, and Lancap, the best-selling lansoprazole.

This press release includes statements that constitute "forward-looking statements," including with regard to sales of products. It employs approximately 20,000 people globally, has roughly 1,500 products in its portfolio, with more than 60 dosage forms, and has a presence in more than 150 countries. Dexmedetomidine Hydrochloride Injection, 100 mcg (base)/mL, packaged in 200 mcg (base)/2 mL Single-dose Vials, had U. Resources and information to help prescribe, dispense and take medicine with confidence. It employs more than 10,000 people, its products serve more than 150 countries and its ARVs support approximately 1. As of December 2015, the company had 87 products in the US market. Lupin has 13 manufacturing facilities across India, Japan and Mexico, employing more than 1,600 people globally and is the global leader in manufacturing and marketing generic anti-TB medicines and cephalosporins. Cipla launched the generic Sofosbuvir drug in India under the brand name Hepcvir in March 2015 and Ledipasvir-Sofosbuvir in India called Hepcvir-L in December. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Lovenox is an anti-coagulant used to prevent deep vein thrombosis (DVT), while Plavix is indicated primarily for acute coronary syndrome.


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