Generics

Safety and efficacy of generic tenofir/lamivudine/efavirenz combination

Generics/Research | Posted 14/12/2012

New research shows the safety and efficacy of a generics combination of tenofir, lamivudine and efavirenz in the treatment of HIV-infected patients in Thailand [1].

Overview of research on ‘specific’ policies aimed at generics in 2012

Generics/Research | Posted 14/12/2012

Period: January to August 2012

Countries around the world have embraced generics due to their cost-saving potential. Many governments already have policies in place to promote the use of generic medicines, and as health systems face continuous cost pressures and demands to invest in new technologies, generics can only become more important.

Black-box safety warnings and the future of generic drug liability

Generics/Research | Posted 07/12/2012

Generic medicines currently have no responsibility for adding warnings about adverse effects of their medicines. Despite the US Supreme Court ruling that it was ‘impossible’ to force generics manufacturers to update their labels with the latest warnings, many feel that they have an ethical responsibility to do just that [1].

Ranbaxy not the only Indian generics maker subject to FDA recalls

Generics/News | Posted 07/12/2012

It seems that Ranbaxy Pharmaceuticals (Ranbaxy) is not the only Indian generics manufacturer who has been subjected to FDA recalls. It now comes to light that Dr Reddy’s Laboratories (Dr Reddy’s) and Aurobindo Pharma (Aurobindo) have also had to recall key generic drugs during 2012.

Overview of research on ‘general’ policies aimed at generics in 2012

Generics/Research | Posted 30/11/2012

Period: January to August 2012

Many governments around the world already have policies in place to promote the use of generic medicines, and with the increasing cost of health care and restrictions on budgets the need for low cost, quality medications can only become more important.

The ethics of generic drug liability

Generics/Research | Posted 30/11/2012

What responsibility should the manufacturers of generic medicines bear for warnings about adverse effects of their medicines? Indeed, what responsibility should be borne by the original manufacturers of these drugs? What happens if an adverse effect is noticed after the drug has been in use for many years? Such questions are being pondered in the US after a recent ruling in which the Supreme Court decided it was ‘impossible’ to force generics manufacturers to update their labels with the latest warnings.

India urged to drop cost-based drug policy

Generics/General | Posted 30/11/2012

Indian industry trade group the Associated Chambers of Commerce and Industry of India (ASSOCHAM) has urged the Indian Government to drop its cost-based price controls on both brand-name and generic drugs and instead introduce a market-based pricing policy.

Ranbaxy recalls generic atorvastatin in US

Generics/News | Posted 30/11/2012

Ranbaxy Pharmaceuticals (Ranbaxy) has fallen foul of FDA once again. The Indian generics major announced on its US website that it is conducting a voluntary recall for certain batches of its atorvastatin calcium tablets, a generic version of Pfizer’s blockbuster cholesterol-reducing drug Lipitor.

History and future of pay-for-delay

Generics/Research | Posted 23/11/2012

Pay-for-delay is a constant issue in both the US and Europe. But how did these settlements first come about and how have US courts attitudes towards such deals affected the pharmaceutical market [1].

Alleviating concerns around generic antiepileptic medications

Generics/Research | Posted 23/11/2012

Reports that some patients with epilepsy were more likely to experience seizures and hospitalisation after switching from brand-name drugs to generic alternatives have led to concerns about generic antiepilepsy drugs (AEDs). A recent review, however, argues that the onset of seizures following a switch may be due more to the disruption of normal routine than the choice of medication. The authors suggest that AEDs are relatively safe and effective compared to innovator drugs.

Generics competition for Pfizer’s sildenafil

Generics/News | Posted 23/11/2012

Apotex Corporation, Dr Reddy’s Laboratories, Mylan, Torrent Pharmaceuticals and Watson Laboratories have all received FDA approval for bioequivalent generic versions of Pfizer’s Revatio (sildenafil citrate – Viagra in Europe) in the US market following the approval by FDA of the generics companies abbreviated new drug applications (ANDAs) for sildenafil tablets.

FDA grant to study generic versus brand-name transplant drugs

Generics/Research | Posted 16/11/2012

FDA has given a grant to the University of Cincinnati, Ohio, USA, in order to support a study into a commonly used immunosuppressive drug for transplant patients, tacrolimus.

German court rules Seroquel XR patent invalid

Generics/News | Posted 16/11/2012

AstraZeneca has lost another battle to protect its blockbuster anti-psychotic drug Seroquel (quetiapine fumarate) against generics.

EMA approves first generic imatinib

Generics/General | Posted 09/11/2012

EMA’s Committee for Medicinal Products for Human Use (CHMP) announced on 18 October 2012 that the agency had approved a generic version of imatinib.

Overview of clinical research on generics in 2012

Generics/Research | Posted 09/11/2012

Period: January to August 2012

Generic drug alternatives to brand-name prescription medications are becoming increasingly important in the global drug market as governments strive to contain healthcare costs and as an increasing number of prescription drugs lose patent protection.

FDA ordered to let Watson sell generic Actos

Generics/News | Posted 09/11/2012

Watson Pharmaceuticals (Watson) has finally won its legal battle to be able to sell a generic version of Takeda Pharmaceutical’s diabetes drug Actos (pioglitazone hydrochloride). A US judge ordered FDA to approve Watson’s generic pioglitazone against the agency’s decision to bar Watson during the first six months of generics availability.

Momenta versus Amphastar and the safe harbour provision

Generics/General | Posted 26/10/2012

On 3 August 2012, the US Federal Circuit issued a decision holding that the safe harbour* provision of the Hatch-Waxman Act 35 U.S.C. § 271(e)(1) covers post-approval testing as long as it is ‘reasonably related’ to the submission of information to FDA. The case involved was that of Momenta Pharmaceuticals (Momenta) versus Amphastar Pharmaceuticals (Amphastar) (Federal Circuit No. 2012-1062, 8/3/12).

Mylan sues FDA over Ranbaxy’s generic Diovan exclusivity

Generics/News | Posted 26/10/2012

US-based Mylan has sued FDA for refusing to grant approval to sell a generic version of Novartis’s heart treatment, Diovan HCT (valsartan/hydrochlorothiazide), ‘after a competitor failed to get the drug on the market in time’.

Teva withdraws generic antidepressant from US

Generics/News | Posted 19/10/2012

Israel-based Teva Pharmaceutical Industries (Teva), the world’s largest generics manufacturer, has removed its Budeprion XL 300 mg generic version of GlaxoSmithKline’s antidepressant Wellbutrin XL (bupropion) from the US market after regulators said it is not therapeutically equivalent to Wellbutrin XL 300 mg.

FDA gives generics greater importance

Generics/General | Posted 12/10/2012

The Office of Generic Drugs has been promoted to the highest position within FDA because of the great amount of work and income/expenditure now associated with generics.