As instructed by the USFDA, Mylan has extended the expiry date by four months for EpiPen. This decision was announced after a shortage of EpiPen was experienced. The injection shot was given a time limit of four months after the expiration date up to which it can be used. The shortage of the medicine and instruction of use of medicine which is past expiration date has created panic among parents as the new school year is about to start.
Mylan NV’s EpiPen is an allergy injection which infuses medication in order to curb allergic reactions. This injection is used to stop the acute allergic attack called anaphylaxis. By injecting the medication a dose of epinephrine is sent into the body quickly preventing anaphylaxis. Since this attack is common after eating allergic foods such as peanuts, or even after a bee sting, children stock this medicine especially before the start of the school. People prone to this attack tend to carry the injector all the time. The injector which seems to be under shortage is the 0.3 milligram EpiPen product and also its authorized generic. The reviewed data for this was issued by Mylan. The company also gave a warning indicating that the supply and stock of the injection might not be present all the time.
The shortage was due to the result of some manufacturing issues at a Pfizer plant which is in charge of EpiPen supply. The manufacturing issues seem to be ongoing.
EpiPen and Alternative
The allergy injector which is now out of stock in pharmacies is said to have a shelf life of 20 months. Considering Mylan’s stability data, FDA has approved the additional four months of usage. This decision, however, does not apply for the EpiPen Jr. The said injector which uses only half the dose of epinephrine is typically used for kids weighing between 33 pounds and 66 pounds.
It was inferred from the statement of Dr.Janet, The director of FDA’s Center for Drug Evaluation and Research, that the FDA is taking necessary steps to avoid a shortage of the allergy injector. Increasing the manufacturing of EpiPen was also considered, and the FDA is working alongside the manufacturer to ensure this. This shortage has affected the stock up of allergy injectors during the back to school time.
A contributing factor to this situation was because EpiPen is the only allergy injector that has the approval from FDI. Considering the facts, the FDA has given the green flag to the generic competitor of EpiPen. The approval which was given earlier this month was for the first competitor in this category. However, the availability of this generic competitor in the market is still not confirmed. The injector from the competition, Teva Pharmaceuticals might reach the shelf only after a few months.
A few other competitors in this category are the Adrenaclick and Auvi-Q. Their products are similar to that of EpiPen but are not exactly the same.