Microgenics zolpidem 510 k?

Microgenics Corporation received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its zolpidem tartrate tablets [1]. This clearance allows Microgenics to market its generic version of Ambien, a sleep-aid medication [1].

When did Microgenics' zolpidem get FDA clearance?

Microgenics announced on March 12, 2007, that it had received 510(k) clearance for its zolpidem tartrate tablets [1]. This clearance means the FDA has determined that the generic drug is substantially equivalent to the innovator product [1].

What is zolpidem used for?

Zolpidem tartrate is a medication used for the short-term treatment of insomnia [1]. It is a non-benzodiazepine hypnotic that acts on the central nervous system to induce sleep [1].

What does 510(k) clearance mean for a drug?

A 510(k) is a premarket notification submitted to the FDA by manufacturers of medical devices and, in this case, generic drugs [1]. Clearance means the FDA has determined that the generic product is "substantially equivalent" in terms of safety and effectiveness to a legally marketed predicate device or drug [1]. For generic drugs, this process indicates that the generic version meets the same standards as the brand-name drug [1].

Who is Microgenics Corporation?

Microgenics Corporation is a generic pharmaceutical company that develops and manufactures generic prescription drugs [1]. The company aims to provide affordable alternatives to brand-name medications [1].