Production & Sales - Launches

25 Feb 2020
- Production & Sales
- Launches
Shionogi’s FETROJA now available for treatment of complicated urinary tract infections in US

By PBR Staff Writer

Shionogi announced FETROJA (cefiderocol) is now available in the U.S. for patients 18 years of age or older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, caused by the following susceptible Gram-negative microorganisms: Escherichia coli (E. coli), Klebsiella pneumoniae (K. pneumoniae), Proteus mirabilis (P. mirabilis), Pseudomonas aeruginosa (P. aeruginosa), and Enterobacter cloacae (E. cloacae) complex.
21 Jan 2020
Production & Sales
Launches
Armas Pharmaceuticals adds four generic injectables as first launches of 2020

By PBR Staff Writer

The products are now a part of Armas' consistently growing product line, bringing their portfolio count to eleven
16 Oct 2019
Production & Sales
Launches
Sun Pharma launches Drizalma Sprinkle in US

By PBR Staff Writer

Sun Pharmaceutical Industries announced that one of its wholly owned subsidiaries has launched Drizalma Sprinkle (duloxetine delayed-release capsules) in the US for oral use.
15 Oct 2019
Production & Sales
Launches
Kyowa Kirin launches NOURIANZ in US for treatment of Parkinson’s disease “Off” episodes

By PBR Staff Writer

Kyowa Kirin, Inc. (Kyowa Kirin), an affiliate of Kyowa Kirin Co., Ltd. (TSE: 4151), announced today that NOURIANZ (istradefylline) is now available in the U.S. as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing “off” episodes.
14 Oct 2019
Production & Sales
Launches
Sun Pharma launches CEQUA for treatment of dry eye disease in US

By PBR Staff Writer

Sun Pharmaceutical Industries announced that one of its wholly-owned subsidiaries has commercialised CEQUA (cyclosporine ophthalmic solution) 0.09% in the US.
01 Oct 2019
Production & Sales
Launches
Celltrion to launch Temixys double combination once-daily tablet for HIV treatment in US

By PBR Staff Writer

Celltrion announced that it is launching Temixy in the US, which were approved in November by US Food and Drug Administration (FDA).
07 Aug 2019
Production & Sales
Launches
Ontario provides access to Biktarvy for treatment of HIV

By PBR Staff Writer

Gilead Sciences Canada announced that effective July 31, the Ontario Drug Benefit Program will provide eligible patients with access to Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) tablets, a once-daily single tablet and complete regimen for the treatment of HIV-1 infection in adults. Health Canada granted a Notice of Compliance for BIKTARVY in July 2018.
02 Aug 2019
Production & Sales
Launches
Alvogen, Lotus launch generic version of Navelbine Softgel capsule in Europe

By PBR Staff Writer

Alvogen announced that its subsidiary Lotus Pharmaceuticals has launched Vinorelbine 20, 30 and 80mg soft capsules in Europe.
22 Jul 2019
Production & Sales
Launches
Rising Pharmaceuticals announces the US launch of generic version of Pregabalin Capsules

By PBR Staff Writer

Rising Pharmaceuticals, a Rising Pharma Holdings Inc. company, today announced the U.S. launch & commercial shipment of a generic version of Lyrica, (pregabalin) Capsules, in all eight commercially available strengths (25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, & 300 mg.
15 Jul 2019
Production & Sales
Launches
Sun Pharma launches Ezallor Sprinkle in US for people who have difficulty swallowing

By PBR Staff Writer

Sun Pharmaceutical Industries announced the U.S. launch of Ezallor Sprinkle (rosuvastatin) capsules for the treatment of three types of elevated lipid disorders in people who have difficulty swallowing, a problem that is estimated to affect approximately 30-35% of long-term care residents.

Drug Discovery

Research & Development

Novartis, life sciences firms collaborate with BMGF to fight against COVID-19 disease

ClinOne’s remote clinical trial patient management technology allows pharmaceutical companies to continue clinical research efforts amidst Covid-19 pandemic in accordance with FDA guidelines

Clinical Trials

Patient Enrollment

Artugen Therapeutics announces first patient dosed with ART24

Horizon Therapeutics initiates PROTECT clinical trial of KRYSTEXXA

Regulation

Drug Filing

EMA grants orphan drug designation to AlloVir’s Viralym-M

Infinity gets FDA fast track status for IPI-549, Opdivo combo in urothelial cancer

Production & Sales

Manufacturing

Audentes Therapeutics to build gene therapy manufacturing facility in North Carolina

Dr. Reddy’s Laboratories to acquire select business divisions of Wockhardt in India

Packaging & Supply Chain

Packaging

Gerresheimer

PCI Pharma announces bottling line expansion at Rockford site

Suppliers

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Production & Sales - Launches

Shionogi’s FETROJA now available for treatment of complicated urinary tract infections in US

Armas Pharmaceuticals adds four generic injectables as first launches of 2020

Sun Pharma launches Drizalma Sprinkle in US

Kyowa Kirin launches NOURIANZ in US for treatment of Parkinson’s disease “Off” episodes

Sun Pharma launches CEQUA for treatment of dry eye disease in US

Celltrion to launch Temixys double combination once-daily tablet for HIV treatment in US

Ontario provides access to Biktarvy for treatment of HIV

Alvogen, Lotus launch generic version of Navelbine Softgel capsule in Europe

Rising Pharmaceuticals announces the US launch of generic version of Pregabalin Capsules

Sun Pharma launches Ezallor Sprinkle in US for people who have difficulty swallowing

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Research & Development

Patient Enrollment

Drug Filing

Manufacturing

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