Generics drive Dr Reddy's Q2 revenues up 14%

Generics/News | Posted 23/11/2009

On 23 October 2009, Dr Reddy's Laboratories in India reported a 14% increase in consolidated revenues to Rs18.4 billion (Euros 263.94 million) for the second quarter that ended on 30 September 2009, driven by growth in the generics business.

FDA compared generic and innovator drugs based on 12 years of bioequivalence data

Generics/General | Posted 17/11/2009

In the US, manufacturers seeking approval to market a generic drug product must submit data demonstrating that the generic formulation provides the same rate and extent of absorption as (i.e., is bioequivalent to) the innovator drug product. Thus, most orally administered generic drug products in the US are approved based on results of one or more clinical bioequivalence studies.

Exposure-response analysis on bioequivalent carbamazepine tablets not clinically relevant proof for toxicity differences

Generics/General | Posted 12/11/2009

Generic immediate-release carbamazepine tablets are AB-rated generic versions of Novartis’s Tegratol. In this market, Taro is the leading supplier with half the market. Teva Pharmaceutical Industries Ltd follows with more than a quarter of the market, and Sun’s Caraco is the third-leading supplier with a share of about 18%. The only other supplier currently in the market is Apotex.

Post-marketing pharmacokinetic bioequivalence between generic and branded amoxicillin formulations

Generics/General | Posted 10/11/2009

Amoxicillin is a moderate-spectrum, bacteriolytic, β-lactam antibiotic used to treat bacterial infections caused by susceptible microorganisms. It is usually the drug of choice within the class because it is better absorbed, following oral administration, than other β-lactam antibiotics.

Switching statins in Norway after new reimbursement policy

Generics/Research | Posted 05/11/2009

Norwegian scientists assessed the changes in statins prescribing in Norway after implementation of the new reimbursement regulations for statins in June 2005, as published in the British Journal of Clinical Pharmacology of October 2007 by Ms Solveig Sakshaug of the Norwegian Institute of Public Health in Oslo.

Possible economic benefits from generic and therapeutic statin substitution

Generics/Research | Posted 05/11/2009

The group of Associate Professor O Klungel of Utrecht University, The Netherlands, assessed the potential annual savings due to generic and therapeutic substitution of statin therapy for the general Dutch population, taking the patients’ medical histories into account. Pearl Gumbs and colleagues published the study in the British Journal of Clinical Pharmacology in November 2007.

Actavis launches generic challenge to Pfizer’s Lipitor

Generics/News | Posted 29/10/2009

On 1 October 2009, Actavis, the Iceland-based generic company, launched the most high-profile commercial challenge in Western Europe to Pfizer’s best-selling and patent-protected medicine.

Many potential buyers as sale of Ratiopharm begins

Generics/News | Posted 19/10/2009

The process of divesting Ratiopharm, the world's fourth-largest generic drugmaker, owned by the conglomerate formerly run by German billionaire Mr Adolf Merckle who committed suicide at the start of the 2009 is underway.

FDA approves generic prescription-only version of Plan B emergency contraceptive levonorgestrel for women ages 17 and under

Generics/News | Posted 16/10/2009

The US FDA on 24 June 2009 approved the first generic version of the emergency contraceptive Plan B (levonorgestrel) tablets, 0.75 mg. The generic product will be available by prescription only for women ages 17 and under.

Safety and compliance fears delay UK’s generics substitution

Generics/General | Posted 09/10/2009

Plans to allow pharmacists to save the UK’s National Health Service (NHS) money by overruling doctors' prescriptions for branded medicines have been delayed after concerns about patient safety and compliance.