Launch

Amneal Launches Budesonide Capsules

January 19, 2018

BRIDGEWATER, N.J., Jan. 18, 2018 /PRNewswire/ — Amneal Pharmaceuticals has launched budesonide capsules, 3 mg, an AB-rated equivalent to Entocort® EC.   Annual U.S. sales of budesonide and its generic equivalents were $187 million, according to November 2017 IQVIA™ market data. Budesonide capsules are now shipping to wholesalers, distributors and direct to the trade.   […]

Amicus Therapeutics Launches Galafold™ (Migalastat) for Treatment of Fabry Disease in Spain

January 18, 2018

CRANBURY, N.J. and MADRID, Spain, Jan. 17, 2018 (GLOBE NEWSWIRE) — Amicus Therapeutics (Nasdaq:FOLD), a global biotechnology company at the forefront of rare and orphan diseases, has commenced the commercial launch of the precision medicine Galafold in Spain following final pricing and reimbursement decisions. Galafold is now reimbursed in Spain for long-term treatment of adults […]

Emmaus Life Sciences Announces Availability of Endari™ (L-glutamine oral powder) for Sickle Cell Disease in the United States

January 17, 2018

TORRANCE, Calif.–(BUSINESS WIRE)–Emmaus Life Sciences announced today that Endari is now available by prescription in the United States. Endari was approved by the U.S. Food and Drug Administration (FDA) to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older.   Endari is available by prescription […]

Meditraq launches to simplify serialisation data challenge

January 15, 2018

A new serialisation implementation partner has formed to assist the increasing number of companies needing to meet the data requirements of looming global regulation changes. With the pharmaceutical industry struggling to meet serialisation requirements in over 55 countries, Meditraq supports its customers with the deployment of serialisation software solutions. Part of the Tjoa Group, together […]

Fresenius Kabi Introduces Bortezomib for Injection

January 15, 2018

LAKE ZURICH, Ill.–(BUSINESS WIRE)–Fresenius Kabi announced today the availability in the United States of Bortezomib for Injection. Fresenius Kabi Bortezomib for Injection is available as a single dose vial containing 3.5 mg of lyophilized powder.   “Fresenius Kabi Bortezomib is a cost efficient product alternative for our customers and the patients they treat. We are […]

BioIVT Launches Scientific Advisory Board, Expands Drug Development Expertise

January 12, 2018

New SAB members include a Nobel Laureate, modeling and simulation guru, pediatric oncologist, and bioanalytical operations and infectious disease experts     BioIVT, a leading provider of biospecimens and related services, today announced the launch of its BioIVT Scientific Advisory Board (SAB). BioIVT’s eminent and world-renowned SAB members will provide the company with scientific and […]

Norgine Launches Lymphoseek®▼ in Finland and Sweden

January 11, 2018

AMSTERDAM, January 11, 2018 /PRNewswire/ —   Norgine B.V. today announced the launch of LYMPHOSEEK® (Tc 99m tilmanocept) in Finland and Sweden. LYMPHOSEEK® is a radiopharmaceutical used for diagnostic purposes by nuclear medicine specialists and surgeons. It is specifically designed for a procedure called sentinel lymph node biopsy (SLNB) and represents a significant alternative to […]

New Treatment for House Dust Mite (HDM) – Induced Allergic Rhinitis Now Available in US

January 10, 2018

BEDMINSTER, New Jersey, January 10, 2018 /PRNewswire/ —   Global pharmaceutical company, ALK today announced that its sublingual allergy immunotherapy (SLIT) tablet ODACTRA[TM] is now available through prescription in the US for those 18 years through 65 years of age who suffer from house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis.   (Logo: […]

BYDUREON® BCise™ Injectable Medicine Now Available In The US For Patients With Type-2 Diabetes

January 10, 2018

WILMINGTON, Del., Jan. 10, 2018 /PRNewswire/ — AstraZeneca today announced that BYDUREON® BCise™ (exenatide extended-release) injectable suspension 2mg is now available in pharmacies across the United States. BYDUREON BCise was recently approved by the U.S. Food and Drug Administration for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral antidiabetic […]

Adamas Announces U.S. Commercial Launch of GOCOVRI™ the First and Only FDA-approved Medication for the Treatment of Dyskinesia in Parkinson’s Disease Patients

January 9, 2018

EMERYVILLE, Calif., Jan. 08, 2018 (GLOBE NEWSWIRE) — Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced the full commercial launch of its flagship product, GOCOVRI™ (amantadine) extended release capsules, for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. GOCOVRI was approved by the U.S. Food and Drug […]

Cipher Pharmaceuticals Announces Canadian Launch of OZANEX™ (ozenoxacin cream 1%), a Novel Topical Antibiotic

January 8, 2018

MISSISSAUGA, ON, Jan. 8, 2018 /CNW/ – Cipher Pharmaceuticals Inc. (TSX:CPH) today announced the Canadian launch of OZANEX™ (ozenoxacin cream, 1%), a novel bactericidal topical antibiotic cream indicated for the treatment of impetigo in patients aged 2 months and older1.   “OZANEX represents a new and important treatment alternative for one of the most common […]

Dynavax Announces HEPLISAV-B™ is Now Available in the United States for the Prevention of Hepatitis B in Adults

January 8, 2018

BERKELEY, Calif., Jan. 08, 2018 (GLOBE NEWSWIRE) — Dynavax Technologies Corporation (NASDAQ:DVAX) today announced that HEPLISAV-B™ [Hepatitis B Vaccine (Recombinant), Adjuvanted] is now available in the United States for the prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. HEPLISAV-B was approved by the U.S. […]

Amneal Biosciences Introduces Busulfan Injection, Generic for Busulfex®

January 4, 2018

BRIDGEWATER, N.J., Jan. 4, 2018 /PRNewswire/ — Amneal Biosciences has launched busulfan injection, the company’s AP-rated therapeutic equivalent for Busulfex® 60 mg/10 mL (6 mg/1 mL). The product is supplied in cartons of eight single-dose vials, each containing 60 mg of busulfan in 10 mL of clear sterile solution. It is made without natural rubber […]

ACETO Subsidiary, Rising Pharmaceuticals, Launches Efavirenz Capsules, 50mg and 200mg

January 3, 2018

PORT WASHINGTON, N.Y., Jan. 02, 2018 (GLOBE NEWSWIRE) — ACETO Corporation (NASDAQ:ACET), an international company engaged in the development, marketing, sale and distribution of Human Health products, Pharmaceutical Ingredients and Performance Chemicals, today announced that Rising Pharmaceuticals, its finished dosage form generics subsidiary, has launched the first generic for Efavirenz Capsules, 50mg and 200mg, an […]

H2-Pharma and CHEPLAPHARM Announce Re-Launch of XENICAL® Capsules

January 3, 2018

MONTGOMERY, Ala., Jan. 3, 2018 /PRNewswire/ — H2-Pharma, LLC, a privately held pharmaceutical company, announced today that it has re-launched XENICAL® (orlistat) 120 mg Capsules via its newly formed Branded division. This opportunity arose due to the partnership with CHEPLAPHARM Arzneimittel GmbH, who has recently completed its acquisition of XENICAL® from F. Hoffman-La Roche/Genentech, and […]

Teva Announces Launch of an Authorized Generic of Estrace® Cream in the United States

January 3, 2018

JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced the launch of an authorized generic of Estrace®1 Cream (estradiol vaginal cream, USP, 0.01%), in the U.S.   Estradiol vaginal cream, USP, 0.01%, is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. This launch is […]

H2-Pharma and CHEPLAPHARM Announce Re-Launch of XENICAL® Capsules

January 3, 2018

MONTGOMERY, Ala., Jan. 3, 2018 /PRNewswire/ — H2-Pharma, LLC, a privately held pharmaceutical company, announced today that it has re-launched XENICAL® (orlistat) 120 mg Capsules via its newly formed Branded division. This opportunity arose due to the partnership with CHEPLAPHARM Arzneimittel GmbH, who has recently completed its acquisition of XENICAL® from F. Hoffman-La Roche/Genentech, and […]

Dr. Reddy’s Laboratories announces the launch of Melphalan Hydrochloride for Injection in the U.S. Market

December 27, 2017

HYDERABAD, India & PRINCETON, N.J.–(BUSINESS WIRE)–Dr. Reddy’s Laboratories Ltd (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced today that it has launched Melphalan Hydrochloride for Injection, a therapeutic equivalent generic version of Alkeran® (melphalan hydrochloride) for Injection in the United States market approved by the U.S. Food and Drug Administration (USFDA).   The Alkeran® brand and […]

TESARO Announces Availability of ZEJULA® (niraparib) for Women With Recurrent Ovarian Cancer in Germany

December 15, 2017

ZUG, Switzerland, Dec. 15, 2017 (GLOBE NEWSWIRE) — TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, announced today that ZEJULA® (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, is now available by prescription in Germany. ZEJULA is also currently available for patients in the United Kingdom (UK) who have private insurance. On November 16, the […]

Allakos Secures $100 Million In Series B Financing

December 13, 2017

SAN CARLOS, Calif., Dec. 13, 2017 (GLOBE NEWSWIRE) — Allakos Inc., a private, clinical-stage biopharmaceutical company focused on the development of antibodies for the treatment of allergic, inflammatory and proliferative diseases, today announced the successful completion of a $100 million Series B equity financing. The Series B was led by New Enterprise Associates (NEA) and […]

Alimera Sciences Announces Patients Now Being Treated With ILUVIEN® In Ireland

December 11, 2017

ATLANTA, Dec. 11, 2017 (GLOBE NEWSWIRE) — Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a leader in the commercialization and development of prescription ophthalmic pharmaceuticals, today announced that the first patients in Ireland were treated with ILUVIEN®, its sustained release intravitreal implant for the treatment of diabetic macular edema (DME). “The availability of ILUVIEN in Ireland is […]

Certara Launches Version 17 of its PBPK Simcyp Simulator

December 5, 2017

This year’s Simcyp Simulator enhancements include new oncology and preterm-birth populations, enhanced skin and gut transporter models, and additional regulatory qualification summaries Certara®, the global leader in model-informed drug development and regulatory science, today announced that it has launched version 17 of its Simcyp® Population-based Simulator. “We are proud to introduce several significant advances in […]

TESARO Announces Availability of VARUBI® (rolapitant) IV for Delayed Nausea and Vomiting Associated With Cancer Chemotherapy in the United States

November 28, 2017

WALTHAM, Mass., Nov. 28, 2017 (GLOBE NEWSWIRE) — TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that VARUBI® (rolapitant) IV, is now available in the United States. The U.S. Food and Drug Administration (FDA) approved VARUBI injectable emulsion on October 25, 2017, for use in combination with other antiemetic agents in adults for the […]

Perrigo Announces the Launch of an AB Rated Generic Version of Exalgo® 32mg Extended Release Tablets

November 28, 2017

DUBLIN, Nov. 27, 2017 /PRNewswire/ — Perrigo Company plc (NYSE; TASE: PRGO) today announced the launch of an AB rated generic version of Exalgo® 32mg extended release tablets (hydromorphone HCl) C-II.   Exalgo® 32mg extended release tablets (hydromorphone HCl) C-II is an opioid agonist indicated for the management of moderate to severe pain in opioid […]

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