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Home Industry News Meda asked to give more info on allergy drug

Meda asked to give more info on allergy drug

5th June 2008

More information has been requested on Meda’s new anti-histamine nose spray, which is to be used in the treatment of allergic reactions.

The US Food and Drug Administration (FDA) has asked for more details on the new formulation the drug manufacturer has used in the azelastine hydrochloride nasal spray.

It is said further measures may need to be taken before the approval stage can be reached, with Meda stating it needs to undergo discussions with the authority to clarify the needs of it.

This process may take several months and so delay the approval of the drug.

Meda is also currently seeking approval for an insomnia treatment, which uses a patented technology to allow for fast, effective absorption, according to the firm.

The Sublinox treatment contains one of the world’s most commonly used substances for this disorder, Zolpiderm, with recent phase III studies from Meda showing it gave a faster reaction than the tablet form.

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