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.