Mylan gains final FDA OK for doxycycline 15mg ANDA
Mylan Laboratories says that its Mylan Pharmaceuticals subsidiary has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for doxycycline tablets, 15 mg.
Its doxycycline is the generic version of Par Pharmaceutical's branded product, marketed as Adoxa Tablets by Doak Dermatologics. Doxycycline had US sales of about $34.0 million for the 12 months ending March 31, for the 150mg strength.
In addition to this new product strength, Mylan previously received approval and is marketing the 50mg, 75mg and 100mg strength formulations of the product which, it says, will be shipped immediately.
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