Launch

Fresenius Kabi Melphalan Hydrochloride for Injection Now Available Generic equivalent to ALKERAN® is latest addition to large oncology portfolio

April 18, 2018

LAKE ZURICH, Ill., April 16, 2018 – Fresenius Kabi announced today the immediate availability in the United States of Melphalan Hydrochloride for Injection. Fresenius Kabi Melphalan Hydrochloride for Injection is available as a two-vial kit containing one single dose vial of Melphalan Hydrochloride equivalent to 50 mg Melphalan and one vial of sterile diluent. Fresenius […]

Fresenius Kabi Introduces Palonosetron Hydrochloride Injection Alternative to ALOXI® Now Available

April 12, 2018

LAKE ZURICH, Ill.–(BUSINESS WIRE)–Fresenius Kabi announced today the immediate availability in the United States of Palonosetron Hydrochloride Injection. Fresenius Kabi Palonosetron Hydrochloride Injection is available in a 0.25 mg per 5 mL single dose vial. Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. […]

Dyve™ Biosciences Launches with Groundbreaking Therapeutic Dermal Delivery Technology

April 11, 2018

Technology (Thousand Oaks, California, April/11/2018) Dyve Biosciences officially launched today as a new face in the biopharmaceutical space. The core beliefs of the organization reflect the realization by the leadership team, after many years in traditional corporate environments, that there is a better way to do business; better for patients, better for physicians, and better […]

Acerus Announces Launch of URIVARX® in Canada

April 9, 2018

TORONTO–(BUSINESS WIRE)–Acerus Pharmaceuticals Corporation (TSX:ASP) (“Acerus” or the “Company”) today announced the launch of URIVARX® in Canada less than 3 months after securing the exclusive Canadian rights to the product from Innovus Pharmaceuticals, Inc. (OTCQB: INNV) (“Innovus”) earlier in the year.   Acerus had previously planned for the Canadian launch of URIVARX® in the second […]

Basilea reports launch of antibiotic Zevtera (ceftobiprole) in Canada by Avir Pharma

April 9, 2018

Basel, Switzerland, April 09, 2018 – Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that its partner Avir Pharma Inc. (“Avir Pharma”) has launched Basilea’s hospital antibiotic Zevtera® (ceftobiprole) in Canada. David Veitch, Chief Commercial Officer, said: “We are very pleased with the launch of Zevtera in Canada. We look forward to Zevtera being available to […]

Sunovion Announces Lonhala™ Magnair™ (glycopyrrolate) Inhalation Solution Now Available in the U.S. for the Treatment of COPD

April 6, 2018

MARLBOROUGH, Mass.–(BUSINESS WIRE)–Sunovion Pharmaceuticals Inc. (Sunovion) today announced that Lonhala™ Magnair™ (glycopyrrolate) Inhalation Solution (25 mcg twice daily) is now available at pharmacies in the U.S. for the long-term, maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. LONHALA MAGNAIR is the first nebulized long-acting muscarinic […]

First Annual Model-informed Drug Development Gran Prix Deemed a Success

April 5, 2018

Certara, UNC Eshelman School of Pharmacy and ASCPT staff leverage expertise of leading academic, regulatory and industry KOLs to judge   Certara®, the global leader in model-informed drug development and regulatory science, and faculty at the UNC Eshelman School of Pharmacy today announced the winners of the first Model-informed Drug Development (MIDD) Gran Prix. The […]

Sunovion Announces Lonhala™ Magnair™ (glycopyrrolate) Inhalation Solution Now Available in the U.S. for the Treatment of COPD

April 3, 2018

MARLBOROUGH, Mass.–(BUSINESS WIRE)–Sunovion Pharmaceuticals Inc. (Sunovion) today announced that Lonhala™ Magnair™ (glycopyrrolate) Inhalation Solution (25 mcg twice daily) is now available at pharmacies in the U.S. for the long-term, maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.   “What Are the Signs and Symptoms of […]

Sunovion Announces Lonhala™ Magnair™ (glycopyrrolate) Inhalation Solution Now Available in the U.S. for the Treatment of COPD

April 3, 2018

MARLBOROUGH, Mass.–(BUSINESS WIRE)–Sunovion Pharmaceuticals Inc. (Sunovion) today announced that Lonhala™ Magnair™ (glycopyrrolate) Inhalation Solution (25 mcg twice daily) is now available at pharmacies in the U.S. for the long-term, maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. LONHALA MAGNAIR is the first nebulized long-acting muscarinic […]

Duchesnay USA Announces Launch of Bonjesta® (doxylamine succinate – pyridoxine hydrochloride) in the United States

April 2, 2018

ROSEMONT, PA, April 2, 2018 /PRNewswire/ – Duchesnay USA, a pharmaceutical company specializing in women’s health, announced the launch of Bonjesta® (doxylamine succinate and pyridoxine hydrochloride), multilayer extended-release tablets. Bonjesta is indicated for the treatment of nausea and vomiting of pregnancy (“NVP”) in women who do not respond to conservative management.1   NVP, commonly known […]

Duchesnay USA Announces Launch of Bonjesta® (doxylamine succinate – pyridoxine hydrochloride) in the United States

April 2, 2018

ROSEMONT, PA, April 2, 2018 /CNW Telbec/ – Duchesnay USA, a pharmaceutical company specializing in women’s health, announced the launch of Bonjesta® (doxylamine succinate and pyridoxine hydrochloride), multilayer extended-release tablets. Bonjesta is indicated for the treatment of nausea and vomiting of pregnancy (“NVP”) in women who do not respond to conservative management.1   NVP, ommonly […]

Mylan Introduces Symfi™ Triple Combo Once-Daily HIV Treatment in the U.S.

March 28, 2018

HERTFORDSHIRE, England and PITTSBURGH, March 28, 2018 /PRNewswire/ — Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced that it will introduce in the U.S. a third cost-saving HIV combination. The U.S. Food and Drug Administration (FDA) approved Symfi™ (efavirenz, lamivudine and tenofovir disoproxil fumarate) 600 mg/300 mg/300 mg tablets, a once-daily, single-tablet regimen (STR), […]

New: RImanager Starter Package available for quick and cost effective implementation

March 27, 2018

Best-practice approach jointly developed by Werum IT Solutions and EXTEDO Lüneburg/Munich, Germany, 27 March 2018 – Werum IT Solutions and EXTEDO today announced the launch of RImanager Starter Package. The package includes the RImanager software and a set of services such as software installation, pre-defined and EMA SPOR-compliant configurations, best-practice content, consulting and training. “Statistics […]

Mylan Adds to Growing Oncology Portfolio with Launch of Generic Mutamycin® Injection

March 21, 2018

HERTFORDSHIRE, England and PITTSBURGH, March 20, 2018 /PRNewswire/ — Global pharmaceutical company Mylan N.V. (NASDAQ:MYL) today announced the U.S. launch of 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®. The product is used in […]

Dr. Reddy’s Laboratories Announces the Launch of Levocetirizine Dihydrochloride Tablets USP, 5 mg in the U.S. Market

March 16, 2018

HYDERABAD, India & PRINCETON, N.J.–(BUSINESS WIRE)–Dr. Reddy’s Laboratories Ltd (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced today that it has launched Levocetirizine Dihydrochloride Tablets USP, 5 mg, an over-the-counter therapeutic equivalent generic version of Xyzal® Allergy 24HR Tablets in the United States market as approved by the U.S. Food and Drug Administration (USFDA).   “We […]

Amneal Gains Approval for Erythromycin Tablets USP

March 14, 2018

Amneal Pharmaceuticals has received FDA approval for Erythromycin Tablets USP, 250 mg and 500 mg strengths.  The Amneal product is a therapeutic equivalent for the reference listed drug (RLD) Erythromycin Tablets from Arbor Pharmaceuticals and is the only other immediate release oral tablet available. “Amneal is committed to increasing access to affordable medications,” said Amneal […]

Recipharm completes blow-fill-seal expansion at Kaysersberg facility

March 14, 2018

Recipharm, the contract development and manufacturing organisation (CDMO), announces its new blow-fill-seal machinery is now operational following a substantial investment last year at its facility in Kaysersberg, France. The EUR 18 million investment adds a new blow-fill-seal high-speed filling and packaging line to the site, taking the total number of lines to eight and increasing […]

Certara Launches Industry-First Quantitative Systems Pharmacology (QSP) Consortium on Immuno-oncology with Leading Pharma Company Members

March 13, 2018

Consortium will develop a QSP Immuno-oncology Simulator to test combination cancer therapies and different dose regimens and biomarkers in computer-generated, virtual patients     Certara®, the global leader in model-informed drug development and regulatory science, today announced the launch of its Quantitative Systems Pharmacology (QSP) Immuno-oncology Simulator Consortium.   QSP combines computational modeling and experimental […]

Certara and Faculty from UNC Eshelman School of Pharmacy to Launch New Pharmacometrics Skills Competition at ASCPT 2018 Annual Meeting

March 12, 2018

Certara will co-chair the inaugural MIDD Gran Prix in addition to describing its latest PBPK and MBMA advances in 13 presentations and posters at the conference    Certara®, the global leader in model-informed drug development and regulatory science, today announced that it is partnering with faculty at the UNC Eshelman School of Pharmacy to launch […]

Perrigo Announces Final FDA Approval and Planned Launch for the Store Brand OTC Equivalent of Mucinex® DM Maximum Strength Extended Release Tablets

March 8, 2018

DUBLIN, March 7, 2018 /PRNewswire/ — Perrigo Company plc (NYSE; TASE: PRGO) today announced that it has received final approval from the U.S. Food & Drug administration for the store brand OTC equivalent of Mucinex® DM Maximum Strength (Guaifenesin and Dextromethorphan Hydrobromide Extended-Release Tablets, 1200 mg/60 mg). This product will be packaged and marketed as […]

Bioventus Launches DUROLANE® in the US

March 6, 2018

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologic solutions, today launched DUROLANE, its single-injection, hyaluronic acid (HA) product used for joint lubrication in the treatment of pain associated with knee osteoarthritis (OA). DUROLANE joins three-injection HA GELSYN-3™ and the five-injection HA SUPARTZ FX™ in the company’s OA portfolio making Bioventus the only orthobiologics company in […]

Orbita rolls-out major enhancements to industry-leading voice and conversational AI platform to streamline development of healthcare applications

March 6, 2018

Contact: Beth Strohbusch, Orbita PR Director, beth@orbita.ai, +1 (414) 213-8818 Orbita Voice™ will showcase at HIMSS 2018 in Las Vegas, March 5-8, 2018. Boston, MA – March 5, 2018  – Orbita, Inc. today announced major enhancements to its Orbita Voice™ platform for creating powerful healthcare applications using voice assistive and conversational AI technology such as […]

Basilea reports launch of antibiotic Zevtera (ceftobiprole) in Argentina by Grupo Biotoscana

March 6, 2018

Basel, Switzerland, March 06, 2018 – Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that partner Grupo Biotoscana S.L. (“GBT”) has launched Basilea’s hospital antibiotic Zevtera® (ceftobiprole) in Argentina. David Veitch, Chief Commercial Officer, said: “We are very pleased with the launch of Zevtera in Argentina. This is the first launch of the brand in the […]

Orbita rolls-out major enhancements to industry-leading voice and conversational AI platform to streamline development of healthcare applications

March 6, 2018

Contact: Beth Strohbusch, Orbita PR Director, beth@orbita.ai, +1 (414) 213-8818 Orbita Voice™ will showcase at HIMSS 2018 in Las Vegas, March 5-8, 2018. Boston, MA – March 5, 2018  – Orbita, Inc. today announced major enhancements to its Orbita Voice™ platform for creating powerful healthcare applications using voice assistive and conversational AI technology such as […]

BioIVT Launches New Website, Highlighting Expanded Biospecimen Product and Service Portfolios for Drug Development Researchers

March 5, 2018

Website also sports new scientific resources, streamlined navigation, and enhanced search functionality   BioIVT, a leading provider of biospecimens and related services, today announced the launch of its comprehensive, new, user-friendly website at www.bioivt.com. This launch coincides with the introduction of BioIVT’s new logo and marks the culmination of its new brand rollout.   “BioIVT […]

Mylan to Introduce Two New Cost-Saving HIV Combination Treatments in the U.S.

March 2, 2018

HERTFORDSHIRE, England and PITTSBURGH, March 2, 2018 /PRNewswire/ — Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced that it will launch two new HIV treatments, Symfi Lo™ and Cimduo™, which were approved in February by the U.S. Food and Drug Administration (FDA). Mylan anticipates introducing Symfi Lo in the coming weeks and Cimduo in […]

SUBLOCADE™ (Buprenorphine Extended-Release) is Now Available as First and Only Monthly Injectable Buprenorphine in the U.S. to Treat Patients with Moderate to Severe Opioid Use Disorder

March 1, 2018

SLOUGH, England and RICHMOND, Va., March 1, 2018 /PRNewswire/ — Indivior PLC (LON: INDV) today announced that SUBLOCADE™ (buprenorphine extended-release) injection, for subcutaneous use (CIII), is now available in the United States. SUBLOCADE is approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe opioid use disorder (OUD) in […]

Amneal Launches Generic for Tamiflu® Oral Suspension

March 1, 2018

BRIDGEWATER, N.J., March 1, 2018 /PRNewswire/ — Amneal Pharmaceuticals has launched oseltamivir phosphate for oral suspension, the company’s AB-rated therapeutic equivalent for Tamiflu®, in a 6 mg/mL strength. The powder finished dosage form is made in the U.S.A. and packaged in bottles providing 60 mL of usable volume after constitution. Amneal’s oseltamivir phosphate for oral […]

Amneal Launches Generic for Tamiflu® Oral Suspension

March 1, 2018

Bridgewater, NJ (USA), March 1, 2018 – Amneal Pharmaceuticals has launched oseltamivir phosphate for oral suspension, the company’s AB-rated therapeutic equivalent for Tamiflu®, in a 6 mg/mL strength.  The powder finished dosage form is made in the U.S.A. and packaged in bottles providing 60 mL of usable volume after constitution. Amneal’s oseltamivir phosphate for oral […]

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