Dr Reddy`s gets USFDA nod for generic Zenatane capsules
New Delhi: Drug firm Dr Reddy`s Laboratories today said it has launched its generic Zenatane capsules in the US market following approval from the US health regulator.
The company has launched generic Accutane (Isotretinoin Capsules USP) in the strengths of 20 mg and 40 mg on March 28 following the approval by the US Food & Drug Administration (USFDA) of its abbreviated new drug application (ANDA) for the product in the strengths of 10 mg, 20 mg and 40 mg, Dr Reddy`s said in a statement.
The capsules are generic version of Accutane (Isotretinoin Capsules USP) of Hoffman- La Roche Inc and are used for treating severe recalcitrant nodular acne.
Zenatane capsules of the company in the strengths of 10 mg, 20 mg, & 40 mg will be available in boxes of 30 (3 prescription packs of 10 capsules), Dr Reddy`s said.
Established in 1984, drug major Dr Reddy`s Laboratories offers a portfolio of products in active pharmaceutical ingredients (APIs), custom pharmaceutical services (CPS), generics, biosimilars, differentiated formulations and new chemical entities (NCEs).