Drug Export; GemzarRegister (Gemcitabine Hydrochloride) Bulk Drug or Glass Vials: 200 MG or 1 G (Free Base) Per Vial

Streszczenie

The Food and Drug Administration (FDA) is announcing that Lilly Research Laboratories, A Division of Eli Lilly and Co., has filed an application requesting conditional approval for the export of the human drug Gemzar (gemcitabine hydrochloride) bulk drug or glass vials: 200 mg or 1 g (free base) per vial to France. ADDRESSES: Relevant information on this application may be directed to the Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, and to the contact person identified below. Any future inquiries concerning the export of human drugs under the Drug Export Amendments Act of 1986 should also be directed to the contact person.