Divalproex Sodium Extended-Release tablets are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, as monotherapy and adjunctive therapy and prophylaxis of migraine headaches
Clarithromycin tablets USP, 250 mg and 500 mg have an estimated market size of US $ 11 million for twelve months ending September 2021 according to IQVIA
The company has 271 cumulative ANDA filings with USFDA of which 243 ANDAs have been approved and 28 are pending approval
Only antibody authorised in the US for pre-exposure prophylaxis of COVID-19
Given as few as six times per year and demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF tablets) in reducing the risk of HIV acquisition
The study was performed independently by investigators at the US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research
Evusheld is a combination of two long-acting monoclonal antibodies and is the only antibody therapy authorised in the US to prevent Covid-19
Expanded EUA includes both treatment of patients with Covid-19 and post-exposure prophylaxis (PEP) in high-risk pediatric and infant patients
This further adds to Biocon’s portfolio of vertically integrated complex drug products
Six-months follow-up of prevention trial showed 83% reduced risk of symptomatic Covid-19, with no severe disease or deaths
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