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ANI Pharma Says FDA Approves Methsuximide Capsules, Alendronate Sodium Oral Solution

RTTNews | hace 708

ANI Pharma Says FDA Approves Methsuximide Capsules, Alendronate Sodium Oral Solution

(RTTNews) - ANI Pharmaceuticals, Inc. (ANIP) announced Monday that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Applications (ANDAs) for Methsuximide Capsules USP, 300 mg and Alendronate Sodium Oral Solution 70 mg (base)/75 mL.

Methsuximide Capsules has been granted 180-day Competitive Generic Therapy (CGT) Exclusivity, and Alendronate Sodium Oral Solution is eligible for CGT Exclusivity upon launch.

ANI's Methsuximide Capsules are the generic version of the Reference Listed Drug (RLD) Celontin Capsules and ANI's Alendronate Sodium Oral Solution is the generic version of the RLD Fosamax Oral Solution.

The current annual U.S. market for Methsuximide Capsules and Alendronate Sodium Oral Solution is approximately $6.3 million, according to IQVIA, a leading healthcare data and analytics provider.

Tags: ANIP ANIP,

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ANI Pharma Launches Kionex Suspension For Oral Or Rectal Use

ANI Pharma Launches Kionex Suspension For Oral Or Rectal Use

Biopharmaceutical company ANI Pharmaceuticals, Inc. (ANIP) announced Monday the launch of Kionex (Sodium Polystyrene Sulfonate Suspension USP) for Oral or Rectal use.

RTTNews | hace 337

ANI Pharma Guides FY23 Adj. EPS Below Estimates, But Revenues Above - Update

ANI Pharma Guides FY23 Adj. EPS Below Estimates, But Revenues Above - Update

While reporting financial results for the fourth quarter on Thursday, biopharmaceutical company ANI Pharmaceuticals, Inc. (ANIP) initiates adjusted earnings and net revenue guidance for the full-year 2023.

RTTNews | hace 775

ANI Pharmaceuticals Says FDA Oks ANDA For Clorazepate Dipotassium Tablets

ANI Pharmaceuticals Says FDA Oks ANDA For Clorazepate Dipotassium Tablets

ANI Pharmaceuticals, Inc. (ANIP) announced Wednesday that it has received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Clorazepate Dipotassium Tablets.

RTTNews | hace 1035

Indian Rupee Falls To 2-day Low Against U.S. Dollar

Indian Rupee Falls To 2-day Low Against U.S. Dollar

The Indian rupee weakened against the U.S. dollar in the Asian session on Wednesday, as terrorist attacks in Kashmir, India, weighed on sentiment.

RTTNews | hace 35 minutos

Commodity Currencies Rise Amid Hopes For US-China Trade Deal

Commodity Currencies Rise Amid Hopes For US-China Trade Deal

The commodity currencies such as Australia, the New Zealand and the Canadian dollars strengthened against other major currencies in the Asian session on Wednesday, after U.S. President Donald Trump said tariffs on China would be trimmed down from the current 145 percent rate. Reports also indicate that Treasury Secretary Scott Bessent told a closed-door investor summit he expects the trade dispute between the U.S. and China to de-escalate.

RTTNews | hace 52 minutos

Sensex, Nifty Edge Higher; IT Stocks Take Lead

Sensex, Nifty Edge Higher; IT Stocks Take Lead

Indian shares were notably higher in early trade on Wednesday amid hopes of easing trade tensions between the world's two largest economies and as U.S. President Donald Trump said he had no intention of firing Federal Reserve Chair Jerome Powell.

RTTNews | hace 1h 1min

Canadian Dollar Advances Against Most Majors

Canadian Dollar Advances Against Most Majors

The Canadian dollar strengthened against most major currencies in the Asian session on Wednesday.

RTTNews | hace 1h 16min

NZ Dollar Advances Against Majors

NZ Dollar Advances Against Majors

The New Zealand dollar strengthened against other major currencies in the Asian session on Wednesday.

RTTNews | hace 1h 22min

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