Trade Resources Industry Views Lupin Pharmaceuticals Obtained Final Marketing Approval From FDA for Its Daysee Tablets

Lupin Pharmaceuticals Obtained Final Marketing Approval From FDA for Its Daysee Tablets

Lupin Pharmaceuticals has obtained final marketing approval from FDA for its Daysee tablets (Levonorgestrel and Ethinyl Estradiol Tablets, USP, 0.15mg/0.03mg and Ethinyl Estradiol Tablets, USP, 0.01mg).

The company commenced the shipment of the product, which is generic equivalent to Teva Branded Pharm.'s Seasonique tablets indicated for use by women to prevent pregnancy.

Daysee tablet is packed in Extended-Cycle Wallets, each enclosing a 84 light blue tablets, each comprising 0.15mg of Levonorgestrel and 0.03mg of Ethinyl estradiol, and seven mustard tablets, each comprising 0.01mg of Ethinyl estradiol tablets for 13 weeks.

The light blue tablets debossed with LU on one side and V21 on the other side are round, biconvex, film-coated tablets.

The mustard tablets debossed with LU on one side and V22 on the other side are round, biconvex, film-coated tablets.

 

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/lupin-obtains-final-fda-marketing-approval-for-daysee-tablets-150413
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Lupin Obtains Final FDA Marketing Approval for Daysee Tablets