USFDA approves marketing of generic anti-bacterial drug by Wockhardt

Wockhardt has received approval from the US Food and Drug Administration (FDA) for marketing the generic version of Zosyn.

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Wockhardt has received approval from the US Food and Drug Administration (FDA) for marketing the generic version of Zosyn. A generic version of any drug is a copy of the brand-name drug having exactly the same dosage, intended use, side effects, route of administration, risks, safety, and strength as the original drug. In other words, the pharmacological effects are exactly the same as that of the brand-name counterpart.

Zosyn, manufactured by Wyeth Pharmaceuticals Inc., contains a combination of piperacillin and tazobactam. It is used for treating many bacterial infections such as urinary tract infections, bone and joint infections, severe vaginal infections, stomach infections, skin infections, and pneumonia.

Wockhardt Bio AG, in Mumbai, had filed the application for the product to the US FDA. The abbreviated new drug application (ANDA) was filed in collaboration with Fresinius Kabi, Italy (FKAI) where the product development was completed.
Wockhardt has manufacturing plants in India, UK, Ireland, France and US, and subsidiaries in US, UK, Ireland and France.

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