FDAFinds Problems with Pharmaceutical Drug Companies In India

Several Indian generic pharmaceutical companies,aswell as Americancompanies, with plants in India have come under FDA scrutiny. The American company, Hospira, continues to have produc- tion problems related to their plant in India, which has caused significant supply problems for their injectable products in this country. Ranbaxy, India’s largest pharmaceutical company, reports that U.S. regulators issued an import warning on one of its factory’s products for failing quality control inspections.The FDAstopped imports of 11 drugs from Ranbaxy’s Mohali factory in Punjabprov- ince on Fridaybecause it was deemednot to meet good manufacturing practices.Two otherRan- baxy factories are already under similaralerts from 2009.When USFDA inspectors visited the Wockhardt plant in Chikalthanathey found 16 negative observations including urine spilling over open drains, soiled uniforms and mould growing ina raw-material storage area. This factorywhich makescopiesof a popularheart pill soldin the US turns out to be ajumble of dilapidated buildings with blighted windows, connected by flaking pipes and capped bya rusty roof. The FDA plans on increasing the number of its inspectors form. FDA import bans arepending. Pharmedix® does not purchase products produced in the facilities described above.

New Generic Products

These brandproducts are now availableas thegeneric orwill be by the end of 2013. Contact Pharmedix® customer service for availability and pricing.The products listed are only a partial list of new generic productsthat are now available. The products listedare those which in our opin- ion would beof most interest to our clientbase.

FDALimitsUsageofNizoral(Ketoconazole)OralTablets

The U.S. Food and Drug Administration(FDA) is taking several actions related toNizoral (ketoconazole) oral tablets, including limiting the drug’s use, warning that it can cause severe liver injuries and adrenal gland problems and advisingthat it can lead to harmfuldrug interac- tions with other medications. FDA has approved labelchanges andadded a new Medication Guide to address these safety issues. As a result, Nizoral oral tablets should notbe a first-line treatment forany fungal infection. Nizoral should be used for the treatment of certain fungal infections, known as endemic mycoses,only when alternative antifungal therapies are not available or tolerated. Thetopical formulations of Nizoral have not been associated with liver damage, adrenal problems, or drug interactions. These formulations include creams,sham- poos, foams,and gels applied to the skin, unlike theNizoral tablets, which are taken by mouth