We would first like to thank all our investors for having faith in us and believing in our mission. After a long year of hard work, we have finally secured a drug and started the process to have this drug FDA approved. The estimated time for approval is 8-10 months. We have hired top-notch regulatory consulting firms to assist in this process and have a fully detailed in depth product dossier. Once approved, Dawah will distribute its first drug in the US.
This is one of many sterile injectables and ophthalmic products that Dawah will be slowly rolling out to market through the FDA approval process. Dawah Pharmaceuticals has researched the current market of sterile injectables and ophthalmic drugs. This research has allowed Dawah to prepare a portfolio of drugs to produce that will hold strong in the current marketplace.
Today, the U.S. Food and Drug Administration is providing a summary of the generic drug approval actions for the month of October 2018 as part of its efforts to improve patient access to high-quality, lower cost, safe and effective medicines.
In October, the FDA approved 110 generic drugs and tentatively approved 18 generic drugs, for a total of 128 approval actions. This included 23 first generics for brands that lacked competition and 17 complex generics.
Promoting more generic competition to complex medicines – is a key part of the FDA’s Drug Competition Action Plan, and the agency’s efforts to promote patient access and more affordable medicines.
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