Law may change pre-emption for generics safety labelling
To date generics manufacturers have been exempt from having to change labels to reflect new safety concerns until after the brand-name drug maker changes their labelling. However, this could soon change if Senate Judiciary Committee Chairman Mr Patrick Leahy gets his way. The Senator plans to introduce legislation that would permit generics manufacturers to proactively improve warning information in labelling even before the brand-name drug maker does.

Senator Leahy said ‘The Mensing decision creates a troubling inconsistency in the law with respect to prescription drugs, … if a consumer takes the brand-name version of drug, she can sue the manufacturer for inadequate warnings. If the pharmacy happens to give her the generic version, she will not be compensated for her injuries.’

Senator Leahy intends to introduce the legislation as early as the end of March 2012.

Related article

Generics will not have to change their labelling

Source: Patrick Leahy

Glenmark Generics receives three ANDA approvals
Glenmark Generics received FDA approval of its abbreviated new drug applications (ANDAs) for generic ciclopirox gel 0.77% and levonorgestrel and ethinyl estradiol tablets on 1 March 2012 and for imiquimod cream 5%, their generic version of Medicis Pharmaceutical’s Aldara, on 7 March 2012.

Glenmark’s levonorgestrel and ethinyl estradiol tablets, to be marketed under the branded generic name of Marlissa, are a generic version of Duramed Pharmaceutical’s Nordette tablets. Ciclopirox gel 0.77% is the generic version of Medicis Pharmaceutical’s Loprox gel.

According to IMS Health, the ciclopirox dermatitis treatment had sales for the 12-month period ending September 2011 of greater than US$10 million, while the levonorgestrel and ethinyl estradiol oral contraceptives had sales of approximately US$50.84 million; and the imiquimod cream wart treatment had 2011 sales of approximately US$244 million.

Source: Glenmark Generics