RLD

ANI Pharmaceuticals Announces the Launch of Baclofen Oral Suspension

Retrieved on: 
Tuesday, April 9, 2024
IQVIA, ANI, RLD, Pharmaceutical industry

BAUDETTE, Minn., April 09, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced the launch of Baclofen Oral Suspension, a generic version of the reference listed drug (RLD) Fleqsuvy®.

Key Points: 
  • BAUDETTE, Minn., April 09, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced the launch of Baclofen Oral Suspension, a generic version of the reference listed drug (RLD) Fleqsuvy®.
  • "The launch of Baclofen Oral Suspension represents another entry for ANI into a rapidly growing limited competition market.
  • We are proud of our ability to recognize the market need and provide our customers with the best suited packing configurations to match their requirements in a timely manner,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.
  • U.S. annual sales for Baclofen Oral Suspension total approximately $39 million, according to IQVIA data.

ANI Pharmaceuticals Announces the Launch of Levofloxacin Oral Solution, USP

Retrieved on: 
Wednesday, March 27, 2024
Health, ANI, Growth, RLD, Patient, Pharmaceutical industry

BAUDETTE, Minn., March 27, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced the launch of Levofloxacin Oral Solution, a generic version of the Reference Listed Drug (RLD) Levaquin®.

Key Points: 
  • BAUDETTE, Minn., March 27, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced the launch of Levofloxacin Oral Solution, a generic version of the Reference Listed Drug (RLD) Levaquin®.
  • The current annual U.S. market for Levofloxacin Oral Solution is approximately $7.1 million, according to latest estimates from IQVIA/IMS Health, a leading healthcare data and analytics provider.
  • "New product launch execution remains a top priority for ANI as we continue to drive growth in our Generics business.
  • The launch of Levofloxacin Oral Solution reinforces our ability to respond nimbly to market needs as we pursue our purpose of ‘Serving Patients, Improving Lives,’” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.

UPSHER-SMITH LAUNCHES METHIMAZOLE TABLETS, USP

Retrieved on: 
Friday, March 29, 2024
AB, USP, RLD, Upsher-Smith Laboratories

MAPLE GROVE, Minn., March 29, 2024 /PRNewswire/ -- Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the recent launch of Methimazole Tablets, USP, 5 mg and 10 mg.

Key Points: 
  • MAPLE GROVE, Minn., March 29, 2024 /PRNewswire/ -- Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the recent launch of Methimazole Tablets, USP, 5 mg and 10 mg.
  • The Methimazole Tablet market had U.S. sales of approximately $36.8 million for the 12 months ending December 2023 according to IQVIA.
  • The Therapeutic Equivalence (TE) code for the product is AB, and the original Reference Listed Drug (RLD) was the brand Tapazole®*.

ANI Pharmaceuticals Announces the Launch of Pentoxifylline Extended-Release Tablets, USP

Retrieved on: 
Tuesday, January 23, 2024
Patient, ANI, Health, Tablet, USP, RLD, Therapy, Pentoxifylline, Growth, Pharmaceutical industry

BAUDETTE, Minn., Jan. 23, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced the launch of Pentoxifylline Extended-Release (ER) Tablets, USP 400mg.

Key Points: 
  • BAUDETTE, Minn., Jan. 23, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced the launch of Pentoxifylline Extended-Release (ER) Tablets, USP 400mg.
  • ANI’s Pentoxifylline ER Tablets are the generic version of the Reference Listed Drug (RLD) Trental®.
  • “We are pleased to continue the momentum in our generics business with another launch into a limited competition market.
  • ANI remains committed to driving growth through superior new product launch execution, operational excellence, cost-competitiveness, and supply reliability.

ANI Pharmaceuticals Announces the FDA Approval and Launch of Indomethacin Oral Suspension, USP

Retrieved on: 
Tuesday, January 16, 2024
CGT, Patient, OS, ANI, Health, Food and Drug Administration, USP, RLD, Food, Indometacin, FDA, Abbreviated New Drug Application, Pharmaceutical industry

BAUDETTE, Minn., Jan. 16, 2024 (GLOBE NEWSWIRE) --  ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Indomethacin Oral Suspension (OS), USP.

Key Points: 
  • BAUDETTE, Minn., Jan. 16, 2024 (GLOBE NEWSWIRE) --  ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Indomethacin Oral Suspension (OS), USP.
  • ANI’s Indomethacin OS is the generic version of the Reference Listed Drug (RLD) Indocin® Oral Suspension.
  • The current annual U.S. market for Indomethacin OS is approximately $4.1 million, according to the latest estimates from IQVIA/IMS Health, a leading healthcare data and analytics provider.
  • "With this approval, the FDA has granted Indomethacin OS a Competitive Generic Therapy (CGT) designation, with 180-day exclusivity.

ANI Pharmaceuticals Announces the FDA Approval and Launch of Estradiol Tablets USP

Retrieved on: 
Tuesday, September 12, 2023
Abbreviated New Drug Application, ANI, Food and Drug Administration, Tablet, RLD, Estradiol, Patient, Estradiol valerate, ANDA, FDA, Food, Pharmaceutical industry, IQVIA

BAUDETTE, Minn., Sept. 12, 2023 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Estradiol Tablets USP.

Key Points: 
  • BAUDETTE, Minn., Sept. 12, 2023 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Estradiol Tablets USP.
  • ANI’s Estradiol Tablets USP are the generic version of the Reference Listed Drug (RLD) Estrace®.
  • The According to IQVIA, a leading healthcare data and analytics provider, the current annual U.S. market for Estradiol Tablets USP is approximately $40.9 million.
  • “The approval and launch of Estradiol Tablets, so quickly following our launch last month of Estradiol Gel, exemplifies the ongoing strength of ANI’s Generics portfolio as well as our ongoing commitment in ensuring that patients and providers have access to the high-quality medications they depend on,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.

Mallinckrodt Receives U.S. FDA Approval for Lisdexamfetamine Dimesylate Capsules and Launches Product Used to Treat Attention-Deficit/Hyperactivity Disorder (ADHD)

Retrieved on: 
Thursday, August 31, 2023
Drug, Drug Enforcement Administration, ADHD, CII, Attention deficit hyperactivity disorder, RLD, DEA, FDA, Lisdexamfetamine, Ajman Specialty General Hospital, Generic drug, Dietary supplement, Mallinckrodt, Takeda

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.

Key Points: 
  • 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.
  • Lisdexamfetamine Dimesylate Capsules are a federally controlled substance (CII) used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) and other indications and currently are on the FDA's drug shortage list.
  • Global net sales of Lisdexamfetamine Dimesylate exceeded $3.0 billion in Takeda's fiscal year ended March 31, 2023.
  • Upon receiving approval, which came the day following the expiration of the RLD's pediatric exclusivity, Mallinckrodt began immediate commercialization of the product.

ANI Pharmaceuticals Announces the FDA Approval and Launch of Estradiol Gel, 0.1%

Retrieved on: 
Monday, August 28, 2023
Abbreviated New Drug Application, ANI, Food and Drug Administration, RLD, Patient, Estradiol valerate, ANDA, FDA, Food, Generic drug, IQVIA

BAUDETTE, Minn., Aug. 28, 2023 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Estradiol Gel, 0.1%.

Key Points: 
  • BAUDETTE, Minn., Aug. 28, 2023 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Estradiol Gel, 0.1%.
  • ANI’s Estradiol Gel, 0.1%, is the generic version of the Reference Listed Drug (RLD) Divigel®.
  • The current annual U.S. market for Estradiol Gel, 0.1%, is approximately $42.3 million, according to IQVIA, a leading healthcare data and analytics provider.
  • "The approval and launch of Estradiol Gel, 0.1%, mark an important milestone for ANI, as this is the first topical gel approved from our R&D and manufacturing site in New Jersey.

Nexus Pharmaceuticals Receives FDA Approval for Potassium Chloride for Injection Concentrate, USP

Retrieved on: 
Tuesday, August 15, 2023
Other Manufacturing, FDA, Manufacturing, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, CGT, Hospira, Food and Drug Administration, USP, RLD, Federal Food, Drug, and Cosmetic Act, Potassium chloride, FD, Food, Pharmaceutical industry, Nexus

Nexus Pharmaceuticals announced it has received U.S. Food and Drug Administration (FDA) approval for Potassium Chloride for Injection Concentrate, USP in 10mL and 20mL Single-Dose Vials.

Key Points: 
  • Nexus Pharmaceuticals announced it has received U.S. Food and Drug Administration (FDA) approval for Potassium Chloride for Injection Concentrate, USP in 10mL and 20mL Single-Dose Vials.
  • According to the FDA and the FD&C (Federal Food, Drug, and Cosmetic) Act, the product is considered bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Potassium Chloride for Injection Concentrate, USP, of Hospira, Inc.
  • “This approval highlights Nexus’ commitment to stabilizing the domestic pharmaceutical supply chain,” said Usman Ahmed, President and CEO of Nexus.
  • “Potassium Chloride for Injection Concentrate has been on the FDA’s drug shortage list for several years and we are very proud to alleviate this shortage with a product manufactured in the United States.

UPSHER-SMITH LAUNCHES FAMOTIDINE FOR ORAL SUSPENSION, USP

Retrieved on: 
Tuesday, August 15, 2023
The Cobra Group, AB, Partnership, USP, Upsher-Smith Laboratories, RLD, Approved Drug Products with Therapeutic Equivalence Evaluations, Pharmaceutical industry, Fine chemical, Famotidine

MAPLE GROVE, Minn., Aug. 15, 2023 /PRNewswire/ -- Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the recent launch of Famotidine for Oral Suspension, USP.

Key Points: 
  • MAPLE GROVE, Minn., Aug. 15, 2023 /PRNewswire/ -- Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the recent launch of Famotidine for Oral Suspension, USP.
  • The Famotidine Oral Suspension market had U.S. sales of approximately $73 million for the 12 months ending June 2023 according to IQVIA.
  • The Therapeutic Equivalence (TE) code for Upsher-Smith's product is AB, and the original Reference Listed Drug (RLD) was the brand Pepcid® (famotidine) for oral suspension.
  • *
    This product launch is a result of Upsher-Smith's strategic partnership with Appco Pharma LLC (Appco), a New Jersey-based generic drug development and manufacturing company.