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Dormant drug status can trigger generic access to an alternate Canadian Reference Product

Pharma in Brief

For instance, the generic drug must be “the pharmaceutical equivalent of the [CRP]” and be “bioequivalent with the [CRP]”. Dormant status: A drug listed as “Dormant” in Health Canada’s Drug Product Database means the drug is not presently being sold in Canada, but has not been withdrawn from the market. b) of the Regulations.

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Gelteq IPO: Supporting Gel Technology for Oral Drug Delivery

XTalks

per share, the offering included 1,300,000 ordinary shares, which began trading on the Nasdaq Global Market under the ticker symbol GELS on October 29, 2024. This regulatory strategy leverages bioequivalence studies to expedite approval, positioning Gelteq’s gel as an alternative to traditional oral delivery forms. Priced at $4.0

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The Mesh of the Generics and the Potential of Emerging Therapies in the Smoking Cessation Market

Delveinsight

According to the CDC, in 2018, tobacco companies spent over USD 9 Billion in just promoting and marketing their cigars and cigarettes in the US. Smoking Cessation: What are the drugs available in the market? Chantix is also available in the EU and Japanese Smoking Cessation market. Generics in the Market.

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Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

As biologics have the reputation of being expensive due to their complex nature and production, biosimilars have the ability to improve market access to patients and payors who would otherwise be unable to afford these drugs. To date, the FDA has approved 29 biosimilars, 19 of which are currently being marketed.