Mylan Inc awarded FDA approval for generic Prevacid DR Capsules
MYL | Quote | Chart | News | PowerRating -- Speciality pharmaceutical company Mylan Inc (Nasdaq:MYL) declared on
Tuesday the receipt of final approval from the US Food and Drug
Administration (FDA) for its Abbreviated New Drug Application (ANDA)
for Lansoprazole Delayed- release (DR) Capsules, 15 mg and 30 mg.
This FDA approval was secured by the company's privately held Indian
subsidiary, Matrix Laboratories Ltd.
Lansoprazole DR Capsules will be shipped with immediate effect and will
be sold under the Mylan Pharmaceuticals brand.
The company added Lansoprazole DR Capsules are the generic version of
Tap Pharmaceuticals' proton pump inhibitor Prevacid DR Capsules. The
brand product recorded US sales of approximately USD3bn for the 12
months ending 30 June, according to IMS Health.
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