Glenmark Generics receives final USFDA approval for two ANDA

01 Mar 2012 Evaluate

Glenmark Generics Incorporation, USA, a subsidiary of Glenmark Generics, has received final approval for two abbreviated new drug application’s (ANDA’s) from the United States Food and Drug Administration (USFDA). The approvals are for Ciclopirox Gel 0.77% and Levonorgestrel & Ethinyl Estradiol tablets USP, 0.15 mg/0.03 mg. Glenmark will market this approved oral contraceptive as Marlissa tablets and plans to commence shipping both products immediately.

Ciclopirox Gel 0.77% is the generic version of Loprox Gel, 0.77%, of Medicis Pharmaceutical Corporation. Ciclopirox Gel is indicated for the topical treatment of seborrheic dermatitis of the scalp and is available in 30, 45, and 100 gram tube presentations. According to IMS Health sales data for the 12 month period ending September 2011, Ciclopirox Gel garnered annual sales of greater than $10 million.

Marlissa tablets are Glenmark's generic version of Nordette tablets by Duramed Pharmaceuticals. Marlissa tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. According to IMS Health for the 12 month period ending September 2011 total market sales achieved for Levonorgestrel and Ethinyl Estradiol tablets USP, 0, 15 mg/0.03 mg were approximately $ 50.84 million. This approval marks Glenmark's eight female hormonal product authorized for distribution by the USFDA.

Glenmark's current portfolio consists of 76 products authorized for distribution in the US marketplace. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.

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