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Amneal Pharma Says FDA Approves Lisdexamfetamine Dimesylate Capsules

RTTNews | 1104 days ago

Amneal Pharma Says FDA Approves Lisdexamfetamine Dimesylate Capsules

(RTTNews) - Amneal Pharmaceuticals, Inc. (AMRX) announced Wednesday it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration for lisdexamfetamine dimesylate capsules, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg.

Lisdexamfetamine dimesylate capsules is a generic version of Vyvanse. This ADHD product is currently on the U.S. FDA shortage product list, and Amneal has already begun supplying product to the market.

Lisdexamfetamine dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and above and for adults with moderate to severe Binge Eating Disorder.

According to IQVIA, U.S. annual sales for lisdexamfetamine dimesylate for the 12 months ended June 2023 were $5.3 billion.

Tags: AMRX

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Amneal Pharma Says FDA Accepts For Review ANDA For Naloxone Hydrochloride Nasal Spray

Amneal Pharma Says FDA Accepts For Review ANDA For Naloxone Hydrochloride Nasal Spray

Essential medicines company Amneal Pharmaceuticals, Inc. (AMRX) announced Thursday that the U.S. Food and Drug Administration (FDA) has accepted for review the Abbreviated New Drug Application (ANDA) for naloxone hydrochloride nasal spray, USP, 4mg, which is the generic version of Narcan and is used in the treatment of a known or suspected opioid overdose emergency.

RTTNews | 1292 days ago

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RTTNews | 58 minutes ago

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RTTNews | 1h 11min ago

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RTTNews | 1h 40min ago

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RTTNews | 2h 34min ago

U.S. Dollar Rises Amid Fed Rate Hike Signals

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RTTNews | 4h 38min ago

U.S. Dollar Rises Against Majors

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