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Mylan gets US FDA nod for albuterol ER tabs
Pittsburgh | Friday, February 2, 2007, 08:00 Hrs  [IST]

Mylan Laboratories Inc. has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Albuterol Sulfate extended-release (ER) tablets, 4mg (base) and 8mg (base).

Albuterol Sulfate ER tablets are the generic version of Dava Pharmaceutical's VoSpire ER, which had US sales of approximately $19 million for the same strengths in the 12-month period ending September, 30, 2006, according to IMS Health.

This product will be shipped immediately, a Mylan Laboratories press release stated.

Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories Inc., and a controlling interest in Matrix Laboratories Limited, India.

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