PHARMACY

Seqirus begins shipping 2018-2019 influenza vaccines

BY Sandra Levy

Seqirus has started to ship its portfolio of more than 50 million doses of influenza vaccines to the United States in preparation for the upcoming 2018-2019 influenza season, the company announced Wednesday.

The company will provide Fluad influenza vaccine, adjuvanted, which it said is the only adjuvanted seasonal influenza vaccine specifically developed for people ages 65 years and older, as well as Flucelvax Quadrivalent influenza vaccine, available for those aged four and older, according to the company.

The Seqirus 2018-2019 influenza vaccine portfolio also includes Afluria Quadrivalent, an egg-based quadrivalent influenza vaccine, and Rapivab (peramivir injection), which the company said was the first-and-only one-dose intravenous antiviral treatment for acute uncomplicated influenza.

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Report: Merck’s experimental Ebola vaccine to be used amid Congo outbreak

BY Sandra Levy

Merck’s experimental vaccine is slated to be used today against a new outbreak of Ebola virus in eastern Democratic Republic of Congo, according to a Reuters report.

The vaccine was deployed during its first wide-scale usage against an outbreak in northwestern Congo that was declared over less than two weeks ago.

More than 3,000 doses remain in stock in the capital Kinshasa, enabling authorities to quickly get it to the affected areas near the Ugandan border, said the report.

The vaccination will be administered to health workers and other people who come in contact with confirmed cases of the disease, Barthe Ndjoloko, who oversees the health ministry’s Ebola response, told Reuters.

“Teams are conducting investigations on the ground to identify the contacts of the confirmed cases, including health workers,” Ndjoloko reportedly said in the town of Beni.

Health workers are ensuring that the vaccine is kept well below zero by creating a so-called cold chain, given that in this tropical climate there aren’t reliable power supplies, according to the report.

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FDA OKs first generic under new approval pathway

BY Sandra Levy

The Food and Drug Administration today approved several strengths of potassium chloride oral solution as the first generic drugs to receive a Competitive Generic Therapy designation.

This new approval pathway was created to expedite the development and review of a generic drug for products that lack competition.

Potassium chloride is an oral treatment that is indicated for the treatment and prevention of hypokalemia (low potassium blood levels) in patients who are on diuretics, and when dietary management with potassium-rich foods is insufficient or diuretic dose reduction is not possible.

The FDA gave the nod for Apotex’s potassium chloride oral solution.

“Today’s approval marks the successful implementation of a new program designed to encourage generic drug development for products with inadequate generic competition,” said FDA commissioner Scott Gottlieb, in a press statement.

“The quick implementation of this new pathway is part of our broader effort to foster generic competition and help address the high cost of drugs. So are our efforts to narrow the time it takes for generic drugs to reach the market by reducing the number of review cycles that generic applications typically undergo. This new generic drug application was also approved in its first cycle of review. This approval demonstrates that the competitive generic therapy pathway is efficient and open for business. This pathway is a key step in making safe and effective generic drugs available to patients quickly and ensuring there’s adequate competition so patients have affordable access to the treatments they need,” said Gottlieb.

Under new authorities provided to the agency in the FDA Reauthorization Act of 2017 (FDARA), a drug can be designated as a Competitive Generic Therapy if there is inadequate generic competition for that drug, meaning there is not more than one approved drug in the active section of the Orange Book.

The potassium chloride oral solution products approved (potassium chloride oral solution USP, 10% (20 mEq/15 mL) and 20% (40 mEq/15 mL)) are eligible for 180 days of CGT exclusivity.

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