MSN`s Generic Lisdexamfetamine Dimesylate Receives Approval in the U.S.
Despite the recent loss of exclusivity on Takeda's attention-deficit/hyperactivity disorder (ADHD) heavy hitter Vyvanse, the company's portfolio of newer products continues to hold the sales line.
Amneal Receives U.S. FDA Approval for Lisdexamfetamine Dimesylate
DUBLIN, Aug. 31, 2023 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical company, today announced that its Specialty Generics segment, operating as SpecGx LLC, received approval on August 25, 2023 from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Lisdexamfetamine Dimesylate Capsules 10mg, 20mg, 30mg, 40mg, 50mg, 60mg, and 70mg. The FDA determined SpecGx LLC's product was bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vyvanse® Capsules of Takeda Pharmaceuticals U.S.A., Inc. (Takeda), in all seven of the RLD's approved strengths.
After 16 years on the market, Takeda's blockbuster attention-deficit/hyperactivity disorder (ADHD) med Vyvanse has finally reached its patent cliff.
With generics of the popular ADHD medication Vyvanse circling the gates, Takeda will have to depend on newer launches to grow going forward. Chief among those is the company’s dengue fever vaccine, Qdenga, which the company is focusing on heavily despite a recent setback in the U.S.
Many months into the U.S. shortage of attention-deficit/hyperactivity disorder (ADHD) drug Adderall and its generics, a rival medicine from Takeda is now in short supply.
Sun's Generic Lisdexamfetamine Dimesylate Receives Approval in the U.S.
Ascent's Generic Lisdexamfetamine Dimesylate Receives Receives Approval in the U.S.
As several of Takeda’s top-earning drugs veer toward the patent cliff, the Japanese drugmaker is buckling up for a bumpy ride.