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Glenmark Pharmaceuticals receives ANDA approval for Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg-0.02 mg
Mumbai, August 19, 2015: Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.02 mg, the generic version of Yaz® Tablets of Bayer HealthCare Pharmaceuticals Inc. (Bayer). Glenmark plans to commence shipping of Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.02 mg immediately.
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke.
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke.
According to IMS Health sales data for the 12 month period ending June 2015, the Yaz® market1 achieved annual sales of approximately $170.1 million*.
Glenmark’s current portfolio consists of 101 products authorized for distribution in the U.S. marketplace and 64 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
All brand names and trademarks are the property of their respective owners.
1Market includes brand and all available therapeutic equivalents
*IMS Health National Sales Perspectives: Retail & Non‐Retail, June 2015
About Glenmark Pharmaceuticals Ltd:
Glenmark Pharmaceuticals Ltd. (GPL) is a research‐driven, global, integrated pharmaceutical company headquartered at Mumbai, India. It is ranked among the top 80 Pharma& Biotech companies of the world in terms of revenues. (SCRIP 100 Rankings published in the year 2014). Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). Glenmark has several molecules in various stages of clinical development and is primarily focused in the areas of Inflammation [asthma/COPD, rheumatoid arthritis etc.] and Pain [neuropathic pain and inflammatory pain]. The company has a significant presence in branded generics markets across emerging economies including India. GPL along with its subsidiary has 14 manufacturing facilities in four countries and has six R&D centers.
For further information, please contact: Jason D’Souza / Rajdeep Barooah
Tel: [+91 22] 40189919/984
Email: corpcomm@glenmarkpharma.com