Glenmark Pharmaceuticals’ subsidiary Glenmark Generics has announced they have been granted final approval for two abbreviated new drug approvals ( ANDA’s) from the United States Food and Drug Administration ( USFDA).
Today’s 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 MarlissaTM Tablets and plan 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 USD 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 USD 50.84 million. Today`s 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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Today’s 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 MarlissaTM Tablets and plan 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 USD 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 USD 50.84 million. Today`s 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.
....more info