Mylan N.V. (NASDAQ:MYL) stock was flying high today on approval of a generic drug.
The generic drug that Mylan N.C. got approval for is Glatiramer Acetate Injection 40 mg/mL for 3-times-a-week injection. This is a generic version of Teva Pharmaceutical Industries Ltd (ADR)’s (NYSE:TEVA) Copaxone.
Approval from the U.S. Food and Drug Administration (FDA) means that Mylan N.V. can now sell the generic drug to customers. This drug is designed to treat patients that have relapsing forms of multiple sclerosis (MS).
Now that Mylan N.V. has approval from the FDA for its generic version of Copaxone, it plans to start shipping the drug out immediately. The drug will only be available via prescription. The FDA’s approval means that patients can expect the same results as Copaxone while using the generic version.
Mylan N.V. also notes that the FDA approval letter points out that it was one of the first companies to submit an Abbreviated New Drug Application with a Paragraph IV certification. This means that the company could receive a 180 days of generic drug exclusivity, but a decision on this hasn’t been mad yet. This would be great news for MYL stock.
“Our commitment to the MS patient community extends beyond bringing generic versions of these products to market,” Mylan N.V. CEO Heather Bresch said in a statement. “Mylan also is offering comprehensive patient support services to help patients access therapy as quickly as possible and adhere to a treatment regimen that fits their needs.”
MYL stock was up 19% and TEVA stock was down 14% as of Wednesday afternoon. TEVA stock is also down 55% year-to-date.
As of this writing, William White did not hold a position in any of the aforementioned securities.
