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Commissioner Scott Gottlieb said the approval is part of FDA’s “longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval.” Read More
The FDA Wednesday approved drug products under the Competitive Generic Therapy (CGT) designation for the first time, granting approval to several strengths of Apotex’s potassium chloride oral solution. Read More
Endometriosis, often characterized by chronic pelvic pain, is one of the most common female disorders in the U.S. and affects about one in ten women of reproductive age. Read More