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Bridgewater, NJ (USA), April 27, 2017 – Thiotepa is now available through Amneal Biosciences in both 100 mg/vial and 15 mg/vial as branded TEPADINA® (thiotepa) for injection. The product is supplied as a powder for solution in single-dose vials for intravenous, intracavitary, or intravesical use.
As the exclusive U.S. distributor for TEPADINA®, Amneal Biosciences began shipping the branded thiotepa today from its distribution center in Kentucky. The product is available for purchase through major wholesalers and distributors.
TEPADINA® is approved to reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients with class 3 beta-thalassemia. In addition, the product is approved for the same oncologic indications as generic thiotepa.
TEPADINA® may cause severe marrow suppression, and high doses may cause marrow ablation with resulting infection or bleeding. Hematopoietic progenitor (stem) cell transplantation (HSCT) is required to prevent potentially fatal complications of the prolonged myelosuppression after high doses of TEPADINA®. TEPADINA® should be considered potentially carcinogenic in humans. It is contraindicated in patients with severe hypersensitivity to thiotepa and in concomitant use with live or attenuated vaccines. The most common adverse reactions are neutropenia, anemia, thrombocytopenia, elevated alanine aminotransferase, elevated aspartate aminotransferase, elevated bilirubin, mucositis, cytomegalovirus infection, hemorrhage, diarrhea, hematuria and rash.
Visit http://www.amneal.com/thiotepa-pi for full prescribing information including boxed warning and important safety information for TEPADINA®.
“The introduction of 100 mg thiotepa provides pharmacists with a convenient choice of sizes to accommodate larger doses,” explains Amneal Biosciences President, Charles Lucarelli. “We are thrilled to bring to the U.S. a product that is not only valuable to the pediatric transplant process, but in the 100 mg vial that’s been unavailable for years. Now we have a fully FDA-approved thiotepa molecule with options for the reconstituting pharmacist.”
Amneal Biosciences brings TEPADINA® to the U.S. market on behalf of NDA-holder ADIENNE SA. “This exclusive distribution partnership with ADIENNE further demonstrates Amneal’s ability to successfully commercialize complex products in the U.S.,” says Amneal VP of Global Strategy and Corporate Development, Apurva Saraf. “We continue to pursue such strategic partnerships to complement our expansive and diverse internal pipeline.”
Amneal Biosciences LLC, a wholly-owned subsidiary of Amneal Pharmaceuticals LLC, is dedicated to the commercialization of high-barrier-to-entry generic and specialty pharmaceuticals such as injectables, oncologics, anti-infectives and support care for healthcare providers and patients of all ages. The company’s expertise and focus on the unique needs and logistics of this market ensure the same level of quality and service for healthcare institutions and professionals that Amneal delivers to its retail customers.
Amneal Pharmaceuticals LLC, a privately-held company headquartered in Bridgewater, New Jersey, is one of the largest and fastest growing generic pharmaceutical manufacturers in the United States. Founded in 2002, Amneal now has more than 4,500 employees in its operations in North America, Asia, Australia and Europe, working together to bring high-quality, affordable medicines to patients worldwide.
All trademarks listed in this release are property of their respective owners.
John Niemi (sales)
Vice President, Sales
Cheryl Lechok (media)
President, Cheryl Lechok Communications
Vice President, Global Strategy & Corporate Development
Bridgewater, NJ (USA), April 11, 2017 – Amneal Pharmaceuticals LLC has launched mometasone furoate nasal spray, the company’s first pharmaceutical product in spray form. Mometasone furoate, available in 50 mcg/spray strength, is an AB-rated therapeutic equivalent to Nasonex®.
Amneal’s generic comes packaged in a white, high-density, polyethylene bottle fitted with a white, metered-dose, manual spray pump and turquoise cap. Each 17-gram bottle delivers 120 sprays.
Manufactured in Branchburg, NJ, the product began shipping April 4th through wholesalers, distributors and directly to the trade.
“This launch marks a new milestone for us,” explains Jim Luce, EVP Sales & Marketing. “As the first nasal spray product from Amneal, it stands as yet another example of how we continue to expand into new and more complex dosage forms. Metered dose inhalers, transdermal patches and chewable tablets are just of few of those in the pipeline that we are excited to bring to market, significantly expanding our product offering.”
Click here to view full prescribing information for mometasone furoate nasal spray.
Annual U.S. sales of brand and generic Nasonex® were $653 million according to December 2016 IMS market data.
Click here to download the full release.
All trademarks are property of their respective owner.
Bridgewater, NJ (USA), March 28, 2017 – Amneal Biosciences has launched levoleucovorin for injection, an AP-rated generic equivalent to Fusilev®, in 50 mg strength. Each 50 mg single-dose vial contains a sterile lyophilized powder consisting of levoleucovorin calcium mixed hydrates (equivalent to 50 mg levoleucovorin) and 50 mg mannitol. The product is latex- and preservative-free. It was approved on February 13, 2017 and is now available through wholesalers, distributors and directly to the trade.
Levoleucovorin for injection is the fifth parenteral medication in the market from Amneal Biosciences following eptifibatide, meropenem, fosphenytoin, furosemide and methylprednisolone sodium succinate. The subsidiary also markets oral solids such as temozolomide capsules for the institutional market.
Annual U.S. sales of Fusilev® were $51 million according to December 2016 IMS market data.
Visit https://prd02.apsiva.net/210/GenericCategory/LevoleucovorinforInjection-pi.pdf to view full prescribing information for levoleucovorin for injection.
Bridgewater, New Jersey (USA), January 31, 2017 – Amneal Biosciences has launched its third generic medication for the healthcare institutional market.
Eptifibatide Injection, an AP-rated generic equivalent to Integrilin®, is available in 20 mg (2mg/mL) and 75 mg (0.75 mg/mL) strengths, sold in 10mL and 100mL vials. The product began shipping December 28, 2016 through wholesalers, distributors and directly to the trade.
“We’re very pleased to add eptifibatide to our growing portfolio of high-quality, affordable injectable medicines,” said Charles Lucarelli, Amneal Biosciences president. “Our primary focus remains providing reliable supply to hospitals, clinics and other health facilities as these are often the first line of care for patients.”
Amneal Biosciences (www.amnealbiosciences.com), a wholly-owned subsidiary of Amneal Pharmaceuticals LLC, is dedicated to the commercialization of high-barrier-to-entry generic injectables and specialty pharmaceuticals such as oncologics, anti-infectives and supportive care for healthcare providers and patients of all ages. The company’s expertise and focus on the unique needs and logistics of this market ensure the same level of quality and service for healthcare institutions and professionals that Amneal delivers to its retail customers.
Bridgewater, NJ (USA), January 30, 2017 – Amneal Pharmaceuticals LLC has launched alosetron hydrochloride tablets, an AB-rated generic equivalent to Lotronex®, in 0.5 mg and 1 mg strengths. Manufactured in Brookhaven, NY, the product began shipping in 30-count bottles on January 27 through wholesalers, distributors and directly to the trade.
Alosetron hydrochloride is the second new product to ship from Amneal in the 2017 calendar year following aspirin and extended-release dipyridamole capsules. Alosetron is Amneal’s 105th molecule to be approved through the ANDA process and represents the company’s first product in this therapeutic class. The Amneal product is one of only two FDA-approved generic-equivalents for Lotronex® currently available.
Amneal’s generic received FDA approval under a Risk Evaluation and Mitigation Strategy (REMS) known as the Alosetron REMS Program. Information on this REMS Program is available at https://www.alosetronrems.com or 1-844-267-8675.
Visit http://www.amneal.com/wp-content/uploads/2017/01/AlosetronHydrochloride-pi.pdf to view full prescribing information for alosetron hydrochloride tablets.
Annual U.S. sales of Lotronex® were $50 million according to November 2016 IMS market data.
Click here to view the full press release.