Launch

Amgen Launches The ENBREL Mini™ Single-Dose Prefilled Cartridge With AutoTouch™ Reusable Autoinjector That Is Ergonomically Designed For Patients

November 20, 2017

THOUSAND OAKS, Calif., Nov. 17, 2017 /PRNewswire/ — Amgen (NASDAQ:AMGN) announced that the ENBREL Mini™ with AutoTouch™ is now available in the United States (U.S.). Awarded the Arthritis Foundation Ease of UseSM Commendation, this new and innovative delivery system provides an additional administration option for appropriate ENBREL patients.   The AutoTouch™ reusable autoinjector has an […]

Flexion Therapeutics Announces Full Commercial Launch and Nationwide Availability of ZILRETTA™ (triamcinolone acetonide extended-release injectable suspension)

November 20, 2017

BURLINGTON, Mass., Nov. 20, 2017 (GLOBE NEWSWIRE) — Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced the full commercial launch of ZILRETTA™ (triamcinolone acetonide extended-release injectable suspension), the company’s new therapy for the management of pain associated with osteoarthritis (OA) of the knee. On October 6, 2017, ZILRETTA was approved by the U.S. Food and Drug Administration, […]

EUSA Pharma and AVEO Oncology Announce the First Commercial Launch of FOTIVDA® (tivozanib)

November 15, 2017

HEMEL HEMPSTEAD, England & CAMBRIDGE, Mass.–(BUSINESS WIRE)–EUSA Pharma and AVEO Oncology (NASDAQ:AVEO) today announced the first commercial launch of FOTIVDA® (tivozanib) with the initiation of product sales in Germany. In the European Union, Norway and Iceland, tivozanib is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (aRCC) and for […]

Bioclinica Acquires MDDX Research & Informatics Combining Advanced Image Management Cloud Technology with Its Scientific and Medical Imaging Leadership

November 7, 2017

Best-in-class solution ensures sponsors and CROs have global access to efficient, accurate, and scalable medical imaging to drive better data and outcomes DOYLESTOWN, Pa., Nov. 6, 2017 – Bioclinica®, the world-leading provider of scientific-enabled Medical Imaging, eHealth, and patient-centric solutions supporting clinical research, today announces it has acquired Silicon Valley-based MDDX Research & Informatics, adding […]

Exclusive: Pfizer to launch consumer health sale in November

October 26, 2017

4 MIN READLONDON (Reuters) – Pfizer plans to kick off an auction process for its consumer healthcare business in November, paving the way for a potential $15 billion-plus sale of the headache pill to lip balm business, sources close to the matter told Reuters.   Several global companies, including GlaxoSmithKline and Reckitt Benckiser, have expressed […]

Certara-Monash University Industry Fellowship Program Receives Funding from MTPConnect’s Project Fund Program

October 26, 2017

Fellowship program recognised as a big, bold idea to improve the productivity, competitiveness and innovative capacity of Australia’s medtech, biotech and pharmaceutical sector MTPConnect – the Medical Technologies and Pharmaceuticals Industry Growth Centre – today announced it will provide a proposed AUD750,000 provisional funding to the Certara-Monash University Industry Fellowship Program over two years, with […]

ACETO Subsidiary, Rising Pharmaceuticals, Launches Sertraline Oral Solution, 20mg/ml

October 24, 2017

PORT WASHINGTON, N.Y., Oct. 24, 2017 (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 Sertraline Oral Solution, 20mg/ml, an FDA-approved generic version of reference […]

Shionogi Inc. and Purdue Pharma L.P. Announce U.S. Availability of Symproic® (naldemedine) for the Treatment of Opioid-Induced Constipation in Adults with Chronic Non-Cancer Pain

October 12, 2017

OSAKA, Japan & FLORHAM PARK, N.J. & STAMFORD, Conn.–(BUSINESS WIRE)–Shionogi Inc. and Purdue Pharma L.P. announced today that Symproic® (naldemedine) 0.2 mg tablets are now available throughout the United States. The U.S. Food and Drug Administration (FDA) approved Symproic as a once-daily oral tablet for the treatment of opioid-induced constipation (OIC) in adult patients with […]

Pertinax Pharma launches patented chlorhexidine technology – Pertinax® Novel materials enable controlled and sustained release of chlorhexidine across a multitude of applications

October 10, 2017

10 October 2017: Pertinax Pharma today announces the commercial launch of its unique, proprietary Pertinax® technology, which provides controlled and sustained delivery of chlorhexidine (CHX). The revolutionary new technology has a wide range of potential applications across the wound care, dentistry, medical device and veterinary markets. The advantage of Pertinax is that, unlike conventional CHX […]

Verigo launches Pod Probe: new temperature data logger with built in probe sensor

October 3, 2017

Gainesville, FL — Verigo, a leading provider of wireless temperature monitoring solutions, has added a new model to it’s product suite. Pod Prode is a wireless temperature data logger with a built-in probe sensor that allows to temperature sensing and recording with extreme accuracy and precision. Verigo’s wireless Bluetooth system includes mobile apps and a […]

Mylan Launches Generic Cancidas® for Injection

October 3, 2017

HERTFORDSHIRE, England and PITTSBURGH, Oct. 2, 2017 /PRNewswire/ — Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Caspofungin Acetate for Injection, one of the first generic versions of Merck’s Cancidas®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this antifungal […]

Dr. Reddy’s Laboratories Announces the Launch of Sevelamer Carbonate Tablets in the U.S. Market

October 2, 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 Sevelamer Carbonate Tablets, 800 mg, a therapeutic equivalent generic version of Renvela® (sevelamer carbonate) Tablets, approved by the U.S. Food and Drug Administration (USFDA).   “We are very pleased to bring Sevelamer Carbonate Tablets […]

Mylan Launches Generic Gleevec® Tablets

October 2, 2017

HERTFORDSHIRE, England and PITTSBURGH, Sept. 29, 2017 /PRNewswire/ — Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Imatinib Mesylate Tablets, 100 mg and 400 mg, a generic version of Novartis’s Gleevec® Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for […]

Teva Announces Reintroduction of Generic Depo-Provera® in the United States

September 26, 2017

JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd., (NYSE: TEVA) today announced the reintroduction of the generic equivalent to Depo-Provera®1 Contraceptive Injection (medroxyprogesterone acetate injectable suspension, USP) 150 mg/mL, in the United States. Medroxyprogesterone acetate injectable suspension is a progestin indicated only for the prevention of pregnancy.   “In addition to its importance to patients who will benefit […]

Aytu BioScience Provides Update on the Natesto® U.S. Launch

September 26, 2017

ENGLEWOOD, Colo., Sept. 26, 2017 /PRNewswire/ — Aytu BioScience, Inc. (OTCQX: AYTUD), a specialty life sciences company focused on global commercialization of novel products in the field of urology, today provided an update on the ongoing launch of Natesto in the U.S. Through August 2017, Natesto prescriptions and factory sales have reached their highest levels […]

Cumberland Pharmaceuticals Launches Promotion of Totect® in The U.S. for Emergency Oncology Intervention

September 25, 2017

NASHVILLE, Tenn. and BURTON ON TRENT, England, Sept. 25, 2017 /PRNewswire/ — Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX, ‘Cumberland’) and Clinigen Group plc (AIM:CLIN, ‘Clinigen’), announced today the promotional launch of Totect® (dexrazoxane hydrochloride), in the U.S.   Totect is an FDA-approved hospital based emergency oncology intervention drug, indicated to treat the toxic effects of anthracycline chemotherapy […]

Arbor Pharmaceuticals, LLC Launches New Nymalize® (nimodipine) Oral Solution 10 mL (30 mg) Unit Dose for the Treatment of Subarachnoid Hemorrhage

September 21, 2017

ATLANTA, Sept. 20, 2017 /PRNewswire/ — Arbor Pharmaceuticals, LLC, a U.S.-based specialty pharmaceutical company, announced today that Nymalize® (nimodipine) Oral Solution will now be available in a 10 mL (30 mg) unit dose cup. This new packaging option is designed specifically for patients whom require a dosage that is lower than the standard 20 mL […]

New First Line Treatment Now Available for Canadians with Metastatic Non-Small Cell Lung Cancer

September 21, 2017

KIRKLAND, QC, Sept. 20, 2017 /CNW Telbec/ – Merck (NYSE: MRK), known as MSD outside Canada and the United States, announced today that KEYTRUDA® (pembrolizumab) as monotherapy is now indicated for the treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumours have high PD-L1 expression, with no EGFR or ALK genomic tumour […]

Innovus Pharma Announces the Launch of Zestra® in France, Belgium and Monaco by Its Partner, Densmore

September 19, 2017

SAN DIEGO–(BUSINESS WIRE)–Innovus Pharmaceuticals, Inc. (“Innovus Pharma” or the “Company”) (OTCQB Venture Market: INNV), an emerging over-the-counter (“OTC”) consumer goods and specialty pharmaceutical company engaged in the commercialization, licensing and development of safe and effective non-prescription medicine and consumer care products to improve men’s and women’s health and vitality and respiratory diseases, announced today that […]

Now Available in Canada: ISENTRESS® HD (raltegravir), a New Once-Daily Option, in Combination with Other Antiretroviral Agents, for the Treatment of HIV-1 Infection in Appropriate Patients

September 13, 2017

KIRKLAND, QC, Sept. 12, 2017 /CNW Telbec/ – Merck (NYSE: MRK), known as MSD outside Canada and the United States, today announced the availability of ISENTRESS® HD, a new 1200 mg once-daily dose of the company’s integrase strand transfer inhibitor, ISENTRESS®, to be administered orally as two 600 mg film-coated tablets with or without food, […]

MYDAYIS™ (mixed salts of a single-entity amphetamine product), Shire’s New Once-Daily ADHD Treatment, Now Available in the U.S.

September 12, 2017

LEXINGTON, Mass., Aug. 28, 2017 /PRNewswire/ — Shire plc (LSE:SHP, NASDAQ: SHPG) announced today that MYDAYIS™ (mixed salts of a single-entity amphetamine product), a once-daily, extended-release treatment comprised of three types of drug-releasing beads, is now available by prescription in the United States. The U.S. Food and Drug Administration (FDA) approved Mydayis on June 20, […]

Dr. Reddy’s Laboratories Announces the Launch of Metaxalone Tablets, USP in the U.S. Market

September 6, 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 Metaxalone Tablets, USP 800 mg, a therapeutic equivalent generic version of Skelaxin® (metaxalone) Tablets, approved by the U.S. Food and Drug Administration (USFDA).   The Skelaxin® brand and generic had U.S. sales of approximately […]

Dr. Reddy’s Laboratories Announces the Launch of Bupropion Hydrochloride Extended-Release Tablets, USP (XL) in the U.S. Market

September 6, 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 Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 150 mg and 300 mg, a therapeutic equivalent generic version of Wellbutrin XL® (Bupropion Hydrochloride Extended-Release) Tablets, approved by the U.S. Food & Drug Administration (USFDA).   The […]

Cmed Celebrates One Year Anniversary of encapsia®

August 30, 2017

Cloud-based Clinical Data Suite helps Transform the Speed and Delivery of Clinical Trials HORSHAM, UK — August 30, 2017 – Cmed today announced its one-year anniversary of the launch of encapsia®, an innovative cloud-based clinical data suite of Apps that helps biotech and pharma sponsors transform the way data is captured, monitored and reviewed in clinical trials. […]

Endo Begins Shipment of Generic Sabril® (vigabatrin) for Oral Solution

August 28, 2017

DUBLIN, Aug. 28, 2017 /PRNewswire/ — Endo International plc (NASDAQ: ENDP) announced today that one of its operating companies, Par Pharmaceutical, has begun shipping vigabatrin for oral solution USP, 500 mg per packet following final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application. Par’s vigabatrin for oral solution is […]

Dr. Reddy’s Laboratories Announces the Launch of Cefixime for Oral Suspension, USP in the U.S. Market

August 28, 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 Cefixime for Oral Suspension, USP 100 mg/5mL and 200 mg/5mL, a therapeutic equivalent generic version of Suprax® (cefixime) for Oral Suspension, approved by the U.S. Food and Drug Administration (USFDA).   The Suprax® brand […]

Shire plc : MYDAYIS(TM) (mixed salts of a single-entity amphetamine product), Shire’s New Once-Daily ADHD Treatment, Now Available in the U.S.

August 28, 2017

Lexington, Mass., USA – August 28, 2017 – Shire plc (LSE:SHP, NASDAQ: SHPG) announced today that MYDAYIS(TM) (mixed salts of a single-entity amphetamine product), a once-daily, extended-release treatment comprised of three types of drug-releasing beads, is now available by prescription in the United States. The U.S. Food and Drug Administration (FDA) approved Mydayis on June […]

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