Amneal Pharmaceuticals

Amneal launches generic Taytulla

Amneal launches generic Taytulla

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has launched norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules 1 mg/20 mcg following the July 20th approval of its Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration. The Amneal product, marketed under the proprietary of taysofy, is an AB-rated generic equivalent for the

Amneal gets ANDA approval for acyclovir cream, 5%

Amneal gets ANDA approval for acyclovir cream, 5%

BRIDGEWATER, N.J. —Amneal Pharmaceuticals announced that it has received approval for its Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) for acyclovir cream, 5%. Acyclovir cream, 5%, is the generic version of Zovirax for treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age

Amneal resumes shipping of nizatidine oral solution

Amneal resumes shipping of nizatidine oral solution

BRIDGEWATER, N.J. — Amneal Pharmaceuticals announced that its nizatidine oral solution 15 mg/mL (75 mg/5 mL) is now available for reorder. The drug, the generic equivalent of Axid, is the only oral liquid form of nizatidine available in the US. The Amneal product meets all FDA requirements and specification limits related to NDMA. “Nizatidine has

Amneal launches generic Butrans following ANDA approval by FDA

Amneal launches generic Butrans following ANDA approval by FDA

BRIDGEWATER, N.J. — Amneal Pharmaceuticals announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for a generic version of Butrans (buprenorphine) Transdermal System, 5 mcg/hr, 7.5 mcg/hr, 10 mcg/hr, 15 mcg/hr and 20 mcg/hr. In addition, Amneal was granted the Competitive Generic Therapy (CGT) designation

Amneal among companies to launch generic version of Lyrica

Amneal among companies to launch generic version of Lyrica

BRIDGEWATER, N.J.  — The Food and Drug Administration has approved a number of applications for the generic version of Pfizer’s Lyrica (pregabalin). The  FDA gave the green light to the following companies: Amneal, Alembic, Alkem, Dr. Reddy’s, InvaGen, MSN Laboratories, Rising Pharmaceuticals, Sciegen, and Teva. Amneal’s  generic version of Lyrica (pregabalin capsules) will be available

Amneal announces restructuring and costs savings plan

Amneal announces restructuring and costs savings plan

BRIDGEWATER, N.J. — Amneal Pharmaceuticals announced this week  a comprehensive restructuring plan designed to reduce its cost base, further right size its organization and optimize its global manufacturing infrastructure. “Recently we initiated an in depth, company-wide review of our organizational structures, operational budgets, current and future capital projects, and existing capability and infrastructure alignments,” said

Amneal names Buchen senior VP, chief legal officer and corporate secretary

Amneal names Buchen senior VP, chief legal officer and corporate secretary

BRIDGEWATER, N.J. — Amneal Pharmaceuticals, Inc. has appointed David Buchen to the newly expanded role of senior vice president, chief legal officer and corporate secretary, reporting to oresident and chief executive officer Robert Stewart. Buchen will be responsible for leading Amneal’s global legal, Intellectual Property (IP) and corporate compliance functions, as well as aligning the company’s corporate legal strategies to

Amneal and Impax create diversified pharmaceutical company

Amneal and Impax create diversified pharmaceutical company

BRIDGEWATER, N.J. — Amneal Pharmaceuticals LLC and Impax Laboratories, Inc. announced that they have completed their business combination to form Amneal Pharmaceuticals, Inc. As a diversified company with a robust generics business, Amneal is now the 5th largest generics business in the United States, with a growing, high-margin specialty franchise. Shares of Impax  ceased trading

Amneal launches generic for Sabril

Amneal launches generic for Sabril

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has launched vigabatrin for oral solution USP, a generic equivalent for Sabril. This is the second generic vigabatrin product currently on the market. Each carton contains fifty 500 mg packets. The finished dosage form is manufactured in the United States. “We are pleased to add this critical, specialty product to

Amneal launches two generics

Amneal launches two generics

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has launched two generic drugs, including first-to-market erythromycin tablets. The Amneal erythromycin product, in 250 mg and 500 mg strengths, is a therapeutic equivalent for the reference listed drug erythromycin tablets from Arbor Pharmaceuticals and is the only other immediate release oral tablet available. “Amneal is committed to increasing access to

Amneal releases Entocort EC generic

Amneal releases Entocort EC generic

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has rolled out budesonide capsules 3 mg, a medication for Crohn’s disease. Amneal said its budesonide capsules are a generic version of Entocort EC from AstraZeneca plc. The generic product has begun shipping to wholesalers, distributors and direct to the trade, Amneal added. A steriod medication, budesonide reduces inflammation in the body and is

Allergan COO to become Amneal CEO

Allergan COO to become Amneal CEO

NEW YORK — Merger partners Amneal Pharmaceuticals LLC and Impax Laboratories Inc. have tabbed Robert Stewart, executive vice president and chief operating officer of Allergan plc, to lead the combined company. Plans call for Stewart to join Amneal as president effective Jan. 25. After Amneal and Impax finalize their merger, announced in mid-October, he will

Amneal, Impax agree to merge

Amneal, Impax agree to merge

NEW YORK — Amneal Pharmaceuticals LLC and Impax Laboratories Inc. plan to merge in an all-stock transaction. An Amneal-Impax merger would create the fifth-largest generics supplier by gross revenue in the United States. To be named Amneal Pharmaceuticals Inc., the new entity will also possess a growing, high-margin specialty drug franchise. Financial terms of the deal