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Amneal Pharma Says FDA Approves Lisdexamfetamine Dimesylate Capsules

RTTNews | il y a 537

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 | il y a 725

German Business Confidence Remains Unchanged

German Business Confidence Remains Unchanged

German business morale remained unchanged in February as companies were less satisfied with current situation, while expectations improved moderately amid the federal elections, survey results from the ifo Institute showed on Monday. The ifo business climate index registered 85.2 in February, the same as in January. The score was forecast to rise to 85.9.

RTTNews | il y a 5h 52min

UK Stocks Turning In Mixed Performance; FTSE 100 Modestly Higher

UK Stocks Turning In Mixed Performance; FTSE 100 Modestly Higher

U.K. stocks are modestly higher Monday morning, led by gains in defense shares amid expectations of increased government spending for the sector.

RTTNews | il y a 6h 10min

Sensex, Nifty Tumble; IT Stocks Hit Hard On Tariff Concerns

Sensex, Nifty Tumble; IT Stocks Hit Hard On Tariff Concerns

Indian shares tumbled on Monday, with export-oriented IT stocks coming under heavy selling pressure as weak U.S. economic data rekindled growth worries and U.S. President Donald Trump reiterated that his administration would impose reciprocal tariffs "soon" on countries like India and China.

RTTNews | il y a 6h 30min

CAC 40 Recovers From Early Setback, Down Marginally

CAC 40 Recovers From Early Setback, Down Marginally

After a slightly weak start and a subsequent drop to lower levels, French stocks regained some lost ground Monday morning. The mood remains cautious amid a lack of positive triggers.

RTTNews | il y a 6h 41min

DAX Rises 0.8% As Investors React To Federal Election Results

DAX Rises 0.8% As Investors React To Federal Election Results

German stocks are up firmly in positive territory Monday morning with investors digesting the results of the nation's general election, which saw the Christian Democratic Union of Germany (CDU) emerging victorious.

RTTNews | il y a 6h 58min

U.S. Dollar Falls Amid Prospect Of Fed Rate Cuts

U.S. Dollar Falls Amid Prospect Of Fed Rate Cuts

The U.S. dollar weakened against other major currencies in the Asian session on Monday, as the disappointing U.S. economic data kept the prospect of interest rate cuts by the Federal Reserve (Fed) intact this year.

RTTNews | il y a 7h 3min

European Shares Subdued; DAX Gains After German Vote Outcome

European Shares Subdued; DAX Gains After German Vote Outcome

European stocks were broadly lower on Monday while the euro strengthened amid optimism over German election results.

RTTNews | il y a 7h 51min

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