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FDA, Pharmaceutical Companies, and Stimulant Shortages

January 28, 2012

 

Maryland Public Television has invited me to a live interview by Jeff Salkin on Direct Connection with Jeff Salkin on January 30, 2012 Monday at 7:30 pm to discuss the recent problematic shortage of ADHD stimulant medications. I will review the possible causes and make suggestions to “work around” the shortages for parents and patients.

As a preview to the show and for those who read my blogs, I have provided the FDA’s recent tables highlighting the manufacturers explanations for shortages. You will notice there are several companies making the medications so no one company can be held to blame. This is an industry issue entailing regulatory, manufacturing and economic factors.

Join us Monday night for my detailed explanations. Following the program, I will blog the detailed information I offered in the interview with further links.

http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm

Amphetamine Mixed Salts, ER Capsules  (updated 10/31/2011)

Company/Products Reason Related Information
Shire Customer Service:
1-800-828-2088Adderall XR capsules
5 mg – 100 count (NDC 54092-0381-01); 10 mg – 100 count (NDC 54092-0383-01); 15 mg – 100 count (NDC 54092-0385-01); 20 mg – 100 count (NDC 54092-0387-01); 25 mg – 100 count (NDC 54092-0389-01); 30 mg – 100 count (NDC 54092-0391-01)
API supply issues and uneven product distribution patterns. Product availability for all dosage strengths is adequate.
Teva Customer Service
(888)838-28725 mg – 100 count (NDC 00555-0790-02); 10 mg – 100 count (NDC 00555-0787-02); 15 mg – 100 count (NDC 00555-0791-02); 20 mg – 100 count (NDC 00555-0788-02); 25 mg – 100 count (NDC 00555-0792-02); 30 mg – 100 count (NDC 00555-0789-02)
API supply issues Teva continue to release product as it becomes available.
Global Customer Service:
(215)558-430010 mg ,100 count (NDC 00115-1329-01); 15 mg, 100 count (NDC 00115-1330-01); 20 mg, 100 count (NDC 00115-1331-01); 25 mg, 100 count (NDC 00115-1332-01); 30 mg, 100 count (NDC 00115-1333-01)
Inadequate finished product supply to support current market demand All finished product strengths are currently available on an allocated basis.

Amphetamine Mixed Salts Immediate-Release Tablets (updated 1/12/2012)

Company/Products Reason Related Information
Sandoz Customer Service:
1-609-627-85005 mg tablets, 100 count (NDC 00185-0084-01)10 mg tablets, 100 count (NDC 00185-0111-01)

20 mg tablets, 100 count (NDC 00185-0401-01)

30 mg tablets, 100 count (NDC 00185-0404-01)

Increase in demand Releasing product as it becomes available.
CorePharma
1-800-850-27195 mg tablets, 100 count (NDC 64720-0130-10)10 mg tablets, 100 count (NDC 64720-0132-10)

20 mg tablets, 100 count (NDC 64720-0135-10)

30 mg tablets, 100 count (NDC 64720-0136-10)

Increase in demand CorePharma is releasing product as it becomes available.
Teva Customer Service:
1-888-838-28725 mg tablets, 100 count (NDC 00555-0971-02)7.5 mg tablets, 100 count (NDC 00555-0775-02)

10 mg tablets, 100 count (NDC 00555-0972-02)

12.5 mg tablets, 100 count (NDC 00555-0776-02)

15 mg tablets, 100 count (NDC 00555-0777-02)

20 mg tablets, 100 count (NDC 00555-0973-02)

30 mg tablets, 100 count (NDC 00555-0974-02)

Adderall, 5 mg tablets, 100 count (NDC 00555-0762-02)

7.5 mg tablets, 100 count (NDC 00555-0763-02)

10 mg tablets, 100 count (NDC 00555-0764-02)

12.5 mg tablets, 100 count (NDC 00555-0765-02)

15 mg tablets, 100 count (NDC 00555-0766-02)

20 mg tablets, 100 count (NDC 00555-0767-02)

30 mg tablets, 100 count (NDC 00555-0768-02)

API supply issues Teva continue to release product as it becomes available.

Dextroamphetamine Tablets (1/12/2012)

Company/Products Reason Related Information
Teva Pharmaceuticals
1-800-545-88005 mg tablets, 100 count (NDC 00555-0952-02)
10 mg tablets, 100 count (NDC 00555-0953-02)
Manufacturing delays Teva has dextroamphetamine 5 mg and 10 mg, 100 count tablets, will be on intermittent back order through mid-2012. Product will be released as it becomes available.

Methylphenidate HCl (updated 1/12/2012)

Company/Products Reason Related Information
Sandoz Customer Service:
1-609-627-85005 mg (100s – NDC 00781-8840-01 & 00781-5748-01; 1000s – NDC 00781-8840-10), 10 mg (100s – NDC 00781-5749-01 & 00781-8841-01; 1000s – NDC 00781-1749-10), 20 mg (100s – NDC 00781-8842-01 & 00781-5753-01; 1000s – NDC 00781-1753-10)20 mg (100s – NDC 00781-8843-01 & 00781-5754-01)
Capacity constraints and receiving API orders. Expect sporadic backorders for the next couple of months.
Mallinckrodt Customer Service:
(800) 325-88885 mg (100s – NDC 00406-1121-01; 1000s – NDC 00406-1121-10), 10 mg (100s – NDC 00406-1122-01; 1000s – NDC 00406-1122-10), 20 mg (100s – NDC 00406-1124-01; 1000s – NDC 00406-1124-10) Methylin ER, 10 mg (100s – NDC 00406-1423-01) and 20 mg (100s – NDC 00406-1451-01)
Continued recovery as a result of previously unavailable raw material All strengths of methylphenidate IR and ER tablets will be increasingly available as supply recovery continues, with most contracted orders being met.
UCB Customer Service:
1-800-477-78775 mg (100s – NDC 53014-0531-07), 10 mg (100s – NDC 53014-0530-07), and 20 mg (100s – NDC 53014-0532-07)Metadate ER Tablets, 20 mg (100s – NDC 53014-0594-07)

Metadate CD, 10 mg (100s – NDC 53014-0579-07), 20 mg (100s – NDC 53014-0580-07), 30 mg (100s – NDC 53014-0581-07), 40 mg (100s – NDC 53014-0582-07), 50 mg (100s – NDC 53014-0583-07), and 60 mg (100s – NDC 53014-0584-07)

Increased demand
UCB is currently out of stock of our 5 mg IR, 10 mg IR and 20 mg IR and our 20 mg ER products.  UCB expects resupply by February.
Watson Customer Service:
(973) 355-83005 mg (100s – NDC 00591-5882-01), 10 mg (100s – NDC 00591-5883-01), and 20 mg (100s – NDC 00591-5884-01)
n/a Watson has all 3 strengths available for contracted customers only.
Noven Customer Service:
866.663.2539 
Daytrana (Methylphenidate Transdermal System)
10 mg (30s – NDC 68968-5552-3)
15 mg (30s – NDC 68968-5553-3)
20 mg (30s – NDC 68968-5554-3)
30 mg (30s – NDC 68968-5555-3)
Not applicable
Currently all product is available
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