Drugs Shortages, Oseltamivir Phosphate (Tamiflu) Oral Suspension (Initial Posting Date 1/6/2014) (US FDA, January 7 2014)

[Giuseppe]

[Source: US Food and Drugs Administration (FDA), full page: (LINK). Edited.]


Oseltamivir Phosphate (Tamiflu) Oral Suspension (Initial Posting Date 1/6/2014)

[Company ? Product - Availability and Estimated Shortage Duration - Related Information - Shortage Reason (per New Legislation-FDASIA)* - Date Updated]

• Genentech, Inc.
  • Product support and fulfillment: 1-800-551-2231
  • Medical information: 1-800-821-8590
• Oral Suspension 6 mg/mL; 60 mL (NDC 00004-0820-09)
  • Genentech is experiencing temporary delays in manufacturing of Oral suspension. A brief shortage of Oral Suspension is expected in early--‐mid January.
  • Please check with authorized Genentech distributors and retailers for product availability. Genentech expects to have additional supply of Tamiflu for Oral Suspension mid-January 2014.
• Tamiflu 30 mg, 45 mg and 75 mg capsules remain available. Pediatric patients over 1 year of age can be dosed correctly using the 30 mg and 45 mg capsules.
  • For those patients who cannot swallow capsules, the capsules can be opened and the contents may be mixed with chocolate syrup or some other thick, sweet liquid, as directed by a healthcare professional.
  • If there is difficulty locating commercial Tamiflu for Oral Suspension, FDA would like to remind healthcare professionals of the FDA-approved Instructions for the emergency compounding of an oral suspension from Tamiflu 75 mg capsules. These instructions are in the current package insert and are also posted separately on the manufacturer's website as information for healthcare professionals<SUP>20</SUP> <SUP>21</SUP> regarding compounding an oral suspension from Tamiflu 75 mg capsules.
  • Alternatives to Tamiflu treatment for influenza<SUP>22</SUP> are described on the CDC website.
• Demand increase for the drug
  • New - 1/6/2014

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