On and off "manufacturing delays" at Teva Pharmaceutical (TEVA) are the reason for the Adderall shortage that has been going on in America in recent weeks, the U.S. Food and Drug Administration said this week.
Meanwhile, the company told ABC News that while they are experiencing "intermittent backorders" they are also manufacturing/distributing at the same rate or greater than they were at the same time last year.
According to the company, the supply is the same as it was a year ago but "demand is not."
Amphetamine mixed salts, including Adderall, are FDA-approved for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy.
The FDA says that while there is a shortage, there are alternative therapies, including the extended-release version of amphetamine mixed salts that are available to health care professionals.
To combat the shortage, the FDA says it is monitoring supply and will assist manufacture
Manufacturing delays have forced the FDA to announce a shortage of Adderall or Adderall IR for:
- 100 count 12.5mg
- 100 count 15mg
- 100 count 10mg
- 100 count 20mg
- 100 count 30mg
Those prescriptions are on backorder and recovery isn't expected until March 2023.
Adderall Tablets 10mg 100 counts are on backorder with inventory expected to recover this month. 5mg 100 counts will be available again in November.
Rising Demand
There has been an Adderall shortage since at least the summer, according to the American Society of Health-System Pharmacists, and since the shortage has been hitting generic drug makers like Sandoz, Amneal Pharmaceuticals , and Rhodes Pharmaceuticals (which is a subsidiary of Purdue Pharma), the issue can't just be with Teva.
Between the three of them, the companies sell just over half of all the generic extended-release Adderall in the U.S., Bloomberg reported citing data from Symphony Health.
Israel-based Teva sells more Adderall in the U.S. than any other company.
The National Community Pharmacists Association conducted a survey between July 25 and August 5, with 64% of the 358 respondents saying Adderall was on backorder.
The rise in prescriptions in the U.S. has been attributed to more diagnoses and greater availability of the drug.
Earlier in the year, a Teva spokesperson told Bloomberg that the Adderall delay was a result of a labor shortage.
Teva's Manufacturing Issues
A year ago around this time, Teva announced that it was stopping production at its Irvine, Calif. facility after recalling more than 2.5 million vials of drugs that it said may not be sterile.
The company said the drug vials may have contained mold contamination stemming from water leaks. U.S. inspectors discovered the issue at the company's production plant in Irvine.
The company has temporarily stopped drug production at the facility and says that it is reviewing the concerns raised by the Food and Drug Administration, according to the company's response to Bloomberg.
