Tag: Generics

A generic drug is a pharmaceutical drug that is equivalent to a brand-name product in dosage, strength, route of administration, quality, performance, and intended use. The term may also refer to any drug marketed under its chemical name without advertising, or to the chemical makeup of a drug rather than the brand name under which the drug is sold.

FDA Approved Generic Version of Febuxostat

Novadoz Pharmaceuticals, the U.S based sales & marketing affiliate for MSN Labs, based in Hyderabad India, has received FDA approval for their generic version of Febuxostat 40mg and 80mg tab...

FDA Approved Two Applications for First Generics of Eliquis

The U.S. Food and Drug Administration has approved two applications for the first generics of Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular...

Towa Acquired Esteve Generics Division

TOWA PHARMACEUTICAL CO., LTD. and ESTEVE announced that TOWA will acquire 100% ownership of Pensa Investments, S.L., the generics division of the Spanish pharmaceutical company ESTEVE. The purchase pr...

FDA Approved Amgen AVSOLA™

Amgen continues to grow its portfolio of biosimilar medications with the recent approval of AVSOLA™ (infliximab-axxq) by the U.S. Food and Drug Administration (FDA) on Dec. 6, 2019. Biosimilars are...

FDA Approved Three First Generics of Gilenya

The U.S. Food and Drug Administration has approved three applications for the first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult p...

EC and UK OECD Stressed Importance of Generics and Biosimilars for Healthcare Systems

A joint report has been issued by the European Commission (EC) and the UK Organisation for Economic Co-operation and Development (OECD) on healthcare in the EU, highlighting the importance of generics...

Hikma Submitted Response for Advair® to FDA

hikma
Hikma Pharmaceuticals PLC, the multinational pharmaceutical company, announces that it has submitted to the US Food and Drug Administration (FDA) its response to deficiencies in its abbreviate...

FDA Approved Glenmark Generic Version of Glumetza®

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Metformin Hydrochloride Extended-Release Tablets USP, 5...

Absorption Systems Got FDA Contract to Conduct Testing of Effects of Excipients on Oral Drug Absorpt...

generics
Absorption Systems has been awarded a 2-year contract for a total amount of approximately $300,000 by the U.S. Food and Drug Administration (FDA). The funding mechanism is a Broad Agency Announcement ...

Oakrum and SunGen Launch Generic Methylprednisolone

drugs quality control
Oakrum Pharma, LLC,  in collaboration with SunGen Pharma, LLC, announced the U.S. launch and commercial shipment of a generic version of Medrol® (Methylprednisolone) in 4 mg tablets. It is ...

FDA Approved Glenmark’s Abiraterone Acetate Tablets

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Abiraterone Acetate Tablets USP, 250 mg, a generic vers...

FDA Update on Patient Access to High-Quality, Low-Cost Generics Enhancement

fda
Affordable access to medicines is a public health concern and more generic drug competition can help reduce prices, improve access and benefit the public health. Safe, effective and high-quality gener...

Sun Pharma Launched Drizalma Sprinkle™ in the U.S.

Sun Pharmaceutical Industries Ltd. announced that one of its wholly owned subsidiaries has launched Drizalma Sprinkle™ (duloxetine delayed-release capsules) in the U.S. for oral use. Drizalma Sprin...

FDA Approved Dimethyl Fumarate Delayed-Release Capsules

glenmark
Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Dimethyl Fumarate Delayed-Release Capsules, 120 mg ...

MedicaSafe Announced Partnership with Amneal Pharmaceuticals

partnership
MedicaSafe, Inc. announced a partnership with Amneal Pharmaceuticals, Inc.to provide Amneal’s generic version of Suboxone® (buprenorphine and naloxone) as part of MedicaSafe’s data-generating medicati...

Eisai and Nichi-Iko Entered Collaboration Agreement for Generics in China

generic
Eisai Co., Ltd. and Nichi-Iko Pharmaceutical announced that they have entered into a comprehensive collaboration agreement for the generic pharmaceutical business in China. The Chinese pharmaceutic...