Category Archive: Labeling

/ Labeling

Child-Resistant Packaging – The FDA Outlines What and How to Label Products

By | August 14, 2019 | ANDAs, BLA, FDA, Generics, Labeling, NDA, OTC, Regulatory Affairs | 1 |

In a Federal Register announcement today (here), the FDA announced the availability of a final guidance entitled Child-Resistant Packaging Statements in Drug Product Labeling.  The guidance provides information on the type of statement that may be made on child-resistant packaging for drug products.

As a reminder, the FDA has not regulated child-resistant packaging since 1973,

Potential Label Carve Out to Antidepressant Appears OK to FDA

By | July 23, 2019 | FDA, Generics, Labeling, Petitions, Regulatory Affairs | 1 |

In a 21 page response (here) dated July 18, 2019 to Citizen Petition Docket No. 2019-P-0837 (here  ), filed on February 20, 2019, the FDA determined that a carve out of an exclusivity-based and patent-based (potential little viii) statements regarding a supplemental application approval granting the inclusion of information on treatment of emergent sexual dysfunction would not make an ANDA product less safe or effective than the reference listed drug.