Seven generic manufacturers are approved to launch tamoxifen (equivalent to AstraZeneca's Nolvadex) on Feb. 21. Barr, which marketed an "authorized" generic for a decade until the agreement expired in August, is among those with approved ANDAs. AstraZeneca is already marketing its own generic version (1"The Pink Sheet" Feb. 3, p. 13). Ivax, Mylan, Teva and Roxane Labs 10 mg tablets (60-count) will be priced at $113.10 to $113.77 AWP. AstraZeneca AWP for the generic is $116.98, while branded Nolvadex carries an AWP of $126.41, according to First DataBank's Price Alert. Barr says its price will be below what it offered under the AstraZeneca licensing deal ($121.59 AWP). Andrx also received approval, but says it has no plans to launch due to the number of competitors...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The European Medicines Agency’s ongoing pilot to streamline drug reviews by allowing companies to voluntarily pre-fill factual data in assessment report templates appears to add significant workload for industry, without delivering clear value to regulators.
Talks between the UK government and the pharmaceutical industry that were intended to resolve issues around high clawback rates under the voluntary pricing scheme for branded medicines have failed, meaning that the mechanism used to calculate rebates will remain in place.
After an Aug. 6 safety labeling change, the FDA became aware of “more compelling evidence” that the risk for serious chikungunya-like illness is not limited to older adults, CBER Director Prasad said.
