Glenmark Pharmaceuticals has received tentative approval by the United States Food & Drug Administration (USFDA) for Dabigatran
Etexilate Capsules, 75 mg, 110 mg, and 150 mg, the generic version of Pradaxa1 Capsules, 75 mg, 110 mg, and 150 mg, of Boehringer Ingelheim Pharmaceuticals, Inc.
According to IQVIATM sales data for the 12 month period ending October 2020, the Pradaxa Capsules, 75 mg, 110 mg, and 150 mg market2 achieved annual sales of approximately $550.9 million.
Glenmark s current portfolio consists of 166 products authorized for distribution in the U. S. marketplace and 45 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.
Lung Cancer Therapeutics Market Global Trends, Market Share, Industry Size, Growth, Opportunities and Market Forecast 2020 to 2027
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Glenmark Pharma Share Price Rises Nearly 3% On Tentative Approval From USFDA
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Gainers & Losers: 10 stocks that moved the most on December 21
All sectoral indices ended in the red. The Nifty PSU bank index shed 7 percent, while metal, infra, bank, auto and energy indices fell 4-5 percent. December 21, 2020 / 04:51 PM IST The market snapped its six-day winning streak as it went into a freefall in the second half, dragging Nifty below 13,350 on fears of a new wave of coronavirus in the UK. Mahindra and Mahindra | CMP: Rs 685.95 | Mahindra and Mahindra share price shed more than 6 percent after the company’s farm equipment sector announced that effective January 1, 2021, it will increase the price of its range of tractors across models. This has been necessitated due to the increase in commodity prices.
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On December 2, 2020, Boehringer Ingelheim Pharmaceuticals, Inc. submitted a Citizen Petition to the FDA, requesting that it interpret the term “strength” in section 351(k) of the Public Health Service Act for parenteral solutions to mean “total drug content,” without regard to concentration. Boehringer Ingelheim maintains that this correction would bring the FDA’s interpretation of “strength” in line with the “clear meaning” of the Biologics Price Competition and Innovation Act (“BCPIA”), increase consistency, and prevent “evergreening”, or extending the lifetime of exclusive rights over a parenteral solution. According to Boehringer Ingelheim, the FDA’s current interpretation of “strength” encourages companies “to use minor concentration changes as an anticompetitive tactic to prevent competition from biosimilar and interchangeable biological products, thereby depriving patients from