Examples of 505(b)(2) Applications

Pharmaceutical consulting and generic drug professionals: What are you doing to circumvent the increasingly crowded traditional drug markets?

Many generic companies are turning toward more complex dosage forms, 505(b)(2) development, and even biosimilars. PDG® has compiled a brief summary of seven different, fairly recent 505(b)(2) approvals, including notable features and a tabular overview of each one to show alternatives and at times issues with the submissions.

A few notable drugs discussed in the paper are Bendeka, Narcan and Yosprala. At the end of the paper we have included an excerpt from the 505(b)(2) Draft Guidance ‘Applications Covered by Section 505(b)(2) entitled "WHAT ARE SOME EXAMPLES OF 505(B)(2) APPLICATIONS?’, where the following types of changes are discussed: Dosage form, Strength, Route of administration, Substitution of an active ingredient in a combination product.

Click here to read more on this subject and to find out the other examples of applications that may be accepted pursuant to section 505(b)(2) of the Act.

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