FDA Issues Warning To Mylan Over Valsartan Recall

FDA Issues Warning To Mylan Over Valsartan Recall

Introduction

Mylan Pharmaceuticals received a warning letter from the U.S. Food and Drug Administration with regards to “significant deviations” from good manufacturing practices at its plant in Andhra Pradesh, India.

The warning letter issued on November 5, outlined the issues found during an inspection from May 27 to June 5, 2019. The inspection was the result of a recall of all valsartan batches by Mylan in December after it found that the batches had high levels of nitrosamine, a probable carcinogen. The letter cited that the manufacturer failed to have adequate written procedures for the receipt, identification and handling of raw materials to prevent contamination with nitrosamine impurities and failure to adequately clean equipment and utensils.

The agency issued Mylan 15 business days to respond with corrective measures, also suggested hiring a consultant to help with it.

Valsartan belongs to a class of drugs called Angiotensin II Receptor Antagonist and is used to treat high blood pressure (Hypertension), and Congestive heart failure.

Diovan (Valsartan) was manufactured by Novartis International AG and was approved by the FDA on August 14, 2002. Diovan lost its patent in September 2014. The launch of the generic drug had been on hold since patent expiry due to regulatory problems with the FDA. In 2014, a US-based Ohm Laboratories (Ohm), a subsidiary of Ranbaxy Laboratories, was the first to get the approval from FDA for generic Valsartan. Thereafter, many generic versions of Valsartan came into the market via many other pharma companies.

Valsartan lawsuits are consolidated under MDL No. 2875 (In re Valsartan Products Liability Litigation) in the United States District Court, District of New Jersey, presided by Judge Robert B. Kugler, U.S.D.J and Hon. Joel Schneider, U.S.M.J.