Glenmark Pharmaceuticals receives three ANDA approvals from USFDA
Glenmark also got USFDA nod for Bendamustine Hydrochloride for Injection, 25 mg/vial and 100 mg/vial – its first injectable approved by the USFDA
Mumbai-based Glenmark Pharmaceuticals on Monday announced that it has got ANDA approvals from the United States Food and Drug Administration (USFDA) for its two oral contraceptives - Levonorgestrel tablet, 1.5 mg and Drospirenone and Ethinyl Estradiol tablets, 3 mg/0.03 mg. “Glenmark Pharmaceuticals Inc. has been granted final approval by the USFDA for Drospirenone and Ethinyl Estradiol tablets USP, 3 mg/0.03 mg, the generic version of Yasmin tablets of Bayer HealthCare Pharmaceuticals Inc. (Bayer) and for Levonorgestrel tablet, 1.5 mg, the generic version of Plan B One-Step tablet of Teva Branded Pharmaceutical Products R&D, Inc., for over-the-counter (OTC) use as recommended in the submitted labeling,” Glenmark said in a press release. The drug major, however, cautioned the risk of some serious cardiovascular events due to combination oral contraceptives (COC) use and said COCs should not be given to women with 35 years of age if they still smoke, as this risk increases with age and with the number of cigarettes smoked. In addition, Glenmark also got USFDA nod for Bendamustine Hydrochloride for Injection, 25 mg/vial and 100 mg/vial – its first injectable approved by the USFDA. This drug is therapeutic equivalent to Treanda for Injection, 25 mg/vial and 100 mg/vial, of US-based drug major Cephalon Inc. As per the agreement, Glenmark will launch its product on November 1st, 2019 or maybe earlier if circumstances permit. “Glenmark was one of the first ANDA applicants to submit a substantially complete ANDA with a Paragraph IV certification; therefore, Glenmark may be eligible for 180 days of marketing exclusivity for Bendamustine Hydrochloride for Injection, 25 mg/vial and 100 mg/vial,” the company said. According to sales data by IMS Health, the Treanda for Injection, 25 mg/vial and 100 mg/vial Market1, achieved an annual sale of about $92.6 million for the 12-month period ending January 2016.
March 28, 2016 | 05:50pm IST
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