Glenmark gets two ANDA approvals from USFDA

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Glenmark Pharmaceuticals has received final approval from the US health regulator USFDA for oral contraceptives and leukemia treatment injection.

“Glenmark Pharmaceuticals Inc, USA has been granted final approval by the US Food and Drug Administration (USFDA) for drospirenone and ethinyl estradiol and for levonorgestrel tablets,” it said in a BSE filing.

Drospirenone and ethinyl estradiol are generic version of Bayer Healthcare’s Yasmin tablets and levonorgestrel tablets is generic version of Teva Branded Pharmaceutical Products’ Plan B one-Step tablets.

Glenmark Pharmaceuticals said it also got USFDA’s final approval for bendamustine hydrochloride injection, therapeutic equivalent to Cephalon, Inc’s Treanda.

Treanda is used for treatment of patients with chronic lymphocytic leukemia.

“Today marks Glenmark’s first injectable granted approval by the USFDA,” the company said.

Glenmark said under the terms of prior settlement agreement, it will be able to launch bendamustine hydrochloride injection on November 1, 2019, or earlier under certain circumstances.

“Glenmark was one of the first ANDA (Abbreviated New Drug Applications) applicants to submit a substantially complete ANDA with 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,” it added.

According to IMS Health sales data for the 12 months to January 2016, Glenmark said Treanda achieved annual sales of around $92.6 million.

As per IMS data, Yasmin tablets achieved annual sales of around $131.7 million and Plan B one-Step tablets achieved annual sales of around $45.2 million for the 12 months period ended January 2016.

The company’s current portfolio consists of 112 products authorised for distribution in the US marketplace and 57 ANDA pending approval with the USFDA.

Shares of Glenmark Pharmaceuticals were trading 0.64% up, at Rs 827.35 in the morning trade on BSE.


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