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 Multiple Applications for First Generics of Lyrica

On July 19, the U.S. Food and Drug Administration approved multiple applications for first generics of Lyrica (pregabalin) for the management of neuropathic pain associated with diabetic peripheral ne...

Vision of Russia’s Generic Market Development

The human body is subject to many diseases, so without drugs it simply can not cope. The health of people, the improvement of the quality of life and its duration are the main goals of pharmaceutical ...

Astellas Pharma Announced the Launch of the Smyraf® Tablets

astellas
Astellas Pharma Inc. announced the launch of the Smyraf® 50 mg and 100 mg Tablets (generic name: peficitinib hydrobromide), an oral Janus kinase (JAK) inhibitor, in Japan for the treatment of rheumato...

Lupin Launches Generic of Novartis’ Gleevec®

Lupin Limited (Lupin) announced the launch of Imatinib Mesylate Tablets, 100 mg (base) and 400mg (base). Lupin's alliance partner Natco had received an approval from the United States Food and Drug Ad...

AEMPS Revoked GMP Certificate of Generic Drugmaker Novocat Farma

The Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) last month issued a statement of noncompliance with Good Manufacturing Practice (GMP) and revoked the GMP certificate of Barcelona-b...

Sandoz Announced Launch of Generic Oncology Medicine Gefitinib in 13 EU Countries

Sandoz
Sandoz announced the launch of the generic oncology medicine gefitinib indicated for adult patients with locally advanced or metastatic non-small cell lung cancer with activating mutations of EGFR-TK,...

Lannett to be Exclusive US Distributor of Dantrolene

Lannett Company, Inc. today announced that it has entered into a three-year agreement with Elite Pharmaceuticals to be the exclusive U.S. distributor of a Dantrolene Capsules 25 mg, 50 mg and 100 mg. ...

UK Generic Medicines Market Deliver Significant Savings

uk
A new independent report by economics consultancy Oxera has underlined the critical importance of the United Kingdom generic medicines sector and how, via free competition, it provides sustained and s...

Novartis Won Federal Court Order which Block Gilenya Generics Sale in US

Novartis has won a U.S. federal court order preventing rival generic makers from selling versions of the Swiss drugmaker’s top-selling multiple sclerosis medicine Gilenya in the United States, at leas...

Chinese Plan on Generics Production

The list, which includes drugs that treat serious diseases such as AIDS and leukemia, has been published on the commission's website and is soliciting public opinion for five working days. The Nati...

Teva Launch Generic Version of Tracleer in the U.S.

generics
Teva Pharmaceutical Industries Ltd., announced the launch of a generic version of Tracleer® (bosentan) tablets, 62.5 mg and 125 mg, in the U.S. Bosentan Tablets are an endothelin receptor antagonis...

Glenmark Receives FDA Tentative Approval for Mylan Generic

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Clindamycin Phosphate Foam, 1%, a generic version o...

New FDA Effort to Improve Transparency for Generics Applicants

Statement of the Acting Commissioner of Food and Drugs - Food and Drug Administration, Norman E. "Ned" Sharpless MD on a new effort to improve transparency and predictability for generic drug applican...

Teva Announced the Launch of Generic Version of Ranexa® in the U.S.

Teva Pharmaceutical Industries Ltd. announced the launch of a generic version of Ranexa® (ranolazine) Extended-Release Tablets, 500 mg and 1000 mg, in the U.S. Ranolazine Extended-Release Tablets a...

FDA Published Final REMS Guideline

The U.S. Food and Drug Administration (FDA) affirms its commitment to efficient adoption of Risk Evaluation and Mitigation Strategy (REMS) plans and to making sure they do not impede generic drug deve...

Sandoz to Undergo Workforce Reorganization

Sandoz
Sandoz announces plans for a leaner and more efficient global organization, to drive cost competitiveness as the first stage of its ongoing strategic Transformation and support investments into future...