Content about Amneal Pharmaceuticals

March 25, 2014

The Food and Drug Administration last week approved Amneal Pharmaceuticals' abbreviated new drug application for atovaquone oral suspension USP, 750-mg/5-mL.

SILVER SPRING, Md. — The Food and Drug Administration last week approved Amneal Pharmaceuticals' abbreviated new drug application for atovaquone oral suspension USP, 750-mg/5-mL. 

Atovaquone is the generic equivalent of GlaxoSmithKline's Mepron, indicated for the prevention of Pneumocystis jiroveci pneumonia in patients who are intolerant to trimethoprim-sulfamethoxazole.

January 9, 2014

Amneal Pharmaceuticals has appointed Rochelle Fuhrmann as CFO, the generic drug maker said Thursday.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has appointed Rochelle Fuhrmann as CFO, the generic drug maker said Thursday.

Fuhrmann was formerly SVP finance at Warner Chilcott, where she was responsible for the oversight and direction of the finance and accounting functions, including corporate accounting, financial planning and analysis, tax, treasury, risk management, internal audit and investor relations. She began working at Warner Chilcott in June 2006 and was promoted to SVP in January 2011.

January 6, 2014

Amneal Pharmaceuticals has launched an authorized generic version of a recently launched drug for gastroesophageal reflux disease, the company said.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has launched an authorized generic version of a recently launched drug for gastroesophageal reflux disease, the company said Monday.

December 23, 2013

A federal court decision paves the way for Amneal Pharmaceuticals and its South Korean partnering company to market a drug for treating gastroesophageal reflux disease, the companies said Monday.

BRIDGEWATER, N.J. — A federal court decision paves the way for Amneal Pharmaceuticals and its South Korean partnering company to market a drug for treating gastroesophageal reflux disease, the companies said Monday.

December 17, 2013

Amneal Pharmaceuticals has launched a new treatment for gastroesophageal reflux disease under a partnership with a South Korean drug maker.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has launched a new treatment for gastroesophageal reflux disease under a partnership with a South Korean drug maker.

Amneal announced Tuesday the launch of esomeprazole strontium delayed-release capsules in the 49.3-mg strength, which it is marketing in the United States under a contract with Hanmi Pharmaceutical Co. The drug is expected to begin shipping Wednesday in 30-count bottles.

November 8, 2013

Generic drug maker Amneal Pharmaceuticals will launch its version of a contraceptive product at the beginning of January, the drug maker said.

BRIDGEWATER, N.J. — Generic drug maker Amneal Pharmaceuticals will launch its version of a contraceptive product at the beginning of January, the drug maker said.

Amneal said it would launch its version of 24 Fe (norethindrone acetate and ethinyl estradiol tablets; ferrous fumarate tablets) in the 1 mg/20 mcg and 75 mg strength. As the first company to successfully file for Food and Drug Administration approval of the drug, Amneal's product will have 180 days in which to compete exclusively against the branded version.

October 29, 2013

Generic drug maker Amneal Pharmaceuticals is seeking Food and Drug Administration approval for a gout drug, prompting a lawsuit from the maker of the branded version, according to published reports.

NEW YORK — Generic drug maker Amneal Pharmaceuticals is seeking Food and Drug Administration approval for a gout drug, prompting a lawsuit from the maker of the branded version, according to published reports.

Law360 reported that Takeda Pharmaceuticals USA had sued Amneal in the U.S. District Court for the District of Delaware over the drug Colcrys (colchicine), used to treat gout and familial Mediterranean fever.

September 30, 2013

Amneal Pharmaceuticals has bought rights to four generic drugs from Actavis, Amneal said Monday.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has bought rights to four generic drugs from Actavis, Amneal said Monday.

August 5, 2013

Amneal Pharmaceuticals has introduced five new generic drugs, the company said.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has introduced five new generic drugs, the company said.

The drugs launched are:

Potassium chloride extended-release capsules in the 750-mg strength and in bottle count sizes of 100, 500 and 1,000. The drug is a generic version of Nesher Pharmaceuticals' Micro-K10 ExtenCaps and used to treat potassium deficiency.

Sildenafil tablets in the 20-mg strength and in 90-count bottles. The drug is a generic version of Pfizer's Revatio, used to treat pulmonary arterial hypertension.

June 5, 2013

South Korean drug maker Hanmi Pharmaceutical Co. and U.S. partner Amneal Pharmaceuticals have made an agreement in federal court concerning a generic heartburn drug.

SEOUL, South Korea — South Korean drug maker Hanmi Pharmaceutical Co. and U.S. partner Amneal Pharmaceuticals have made an agreement in federal court concerning a generic heartburn drug that they said clears a major hurdle to its launch.

March 5, 2013

Amneal Pharmaceuticals has started shipping a drug used to treat opioid dependence, the company said Tuesday.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has started shipping a drug used to treat opioid dependence, the company said Tuesday.

The generic drug maker announced the shipment of buprenorphine hydrochloride and naloxone hydrochloride dihydrate sublingual tablets in the 2-mg/0.5-mg and 8-mg/2-mg strengths. The Food and Drug Administration approved the drug in February.

The drug includes a risk evaluation and mitigation strategy, or REMS, a program required by the FDA to ensure that its benefits outweigh its risks.

February 25, 2013

Amneal Pharmaceuticals has received approval from the Food and Drug Administration for a drug to treat opioid dependence.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has received approval from the Food and Drug Administration for a drug to treat opioid dependence.

Amneal announced Monday the approval of buprenorphine hydrochloride and naloxone hydrochloride sublingual tablets, a generic version of Reckitt Benckiser Healthcare's Suboxone.

Suboxone had sales of $1.5 billion in 2012, according to IMS Health.

 

February 21, 2013

The Generic Pharmaceutical Association re-elected its chairman from last year and appointed a new board of directors for 2013 whose members run from A to Z — as in Amneal to Zydus.

ORLANDO, Fla. — The Generic Pharmaceutical Association re-elected its chairman from last year and appointed a new board of directors for 2013 whose members run from A to Z — as in Amneal to Zydus.

"We are grateful for the vision and support of the 2012 board of directors, and we are excited to move ahead with our chairman and our 2013 board," GPhA president and CEO Ralph Neas said. "In a time of enormous change and growth for our industry, leadership is critical."

January 28, 2013

U.S. generic drug maker Amneal Pharmaceuticals has entered a deal with South Korean drug maker Hanmi Pharmaceutical to acquire exclusive distribution rights for a Hanmi drug used for treating gastroesophageal reflux disease, Amneal said Monday.

BRIDGEWATER, N.J. — U.S. generic drug maker Amneal Pharmaceuticals has entered a deal with South Korean drug maker Hanmi Pharmaceutical to acquire exclusive distribution rights for a Hanmi drug used for treating gastroesophageal reflux disease, Amneal said Monday.

September 18, 2012

Generic drug makers Hospira, Sagent Pharmaceuticals and Teva Pharmaceutical Industries have launched generic versions of a chemotherapy drug made by Sanofi, the three companies said last month.


NEW YORK — Generic drug makers Hospira, Sagent Pharmaceuticals and Teva Pharmaceutical Industries have launched generic versions of a chemotherapy drug made by Sanofi, the three companies said last month.


August 6, 2012

Generic drug maker Amneal Pharmaceuticals will spend $120 million to expand three of its plants, the company said Monday.

BRIDGEWATER, N.J. — Generic drug maker Amneal Pharmaceuticals will spend $120 million to expand three of its plants, the company said Monday.

Amneal said it would spend the money over a two-year period lasting through 2014 to "significantly" grow operations at research-and-development, manufacturing and distribution plants in New York, New Jersey and Kentucky. The company, which employs more than 1,100 people in the United States, said the expansion would create 500 more jobs.

May 16, 2012

Amneal Pharmaceuticals is adding blackberry flavoring to a generic diabetes drug following feedback from customers, the company said Wednesday.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals is adding blackberry flavoring to a generic diabetes drug following feedback from customers, the company said Wednesday.

Amneal announced the changes to its metformin hydrochloride immediate-release tablets in the 500-mg, 850-mg and 1,000-mg strengths, designed to cover up the smell of metformin.

March 15, 2012

Amneal Pharmaceuticals has launched a generic version of an antidepressant made by Forest Labs.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has launched a generic version of an antidepressant made by Forest Labs.

The drug maker announced the launch of escitalopram oxalate oral solution in 5-mg/5-mL strength in a peppermint flavor, the company said. The product is a therapeutically equivalent alternative to Lexapro and also marks the first generic version of the drug in liquid form on the market.

Amneal said it has begun shipping the product and is available to wholesalers, distributors, as well as directly to the trade.

December 22, 2011

Amneal Pharmaceuticals has launched its generic version of a drug designed to treat seizures in adults and children with epilepsy.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has launched its generic version of a drug designed to treat seizures in adults and children with epilepsy.

The generic drug maker said it received approval from the Food and Drug Administration on Dec. 16 for felbamate oral suspension in the 600-mg/5-mL strength. The Amneal generic is available in two sizes, 8 fl. oz./240 mL and 16 fl. oz./473 mL. It is a generic version of Meda Pharmaceuticals' antiepileptic Felbatol.

December 13, 2011

Generic drug maker Amneal Pharmaceuticals has added four new executives, the company said.

BRIDGEWATER, N.J. — Generic drug maker Amneal Pharmaceuticals has added four new executives, the company said.

Joseph Todisco has been appointed SVP global corporate strategy and business development. Previously serving as VP business development for Ranbaxy, Todisco will be responsible for the growth of Amneal's U.S. generics business and development of partnerships, mergers and acquisitions.

July 5, 2011

Chirag Patel and Chintu Patel, who respectively are the president and CEO of Amneal Pharmaceuticals, recently received the Ernst & Young Entrepreneur of the Year award.

BRIDGEWATER, N.J. — Chirag Patel and Chintu Patel, who respectively are the president and CEO of Amneal Pharmaceuticals, recently received the Ernst & Young Entrepreneur of the Year award.

The executives received the 2011 New Jersey Award in the pharmaceutical and medical technology category, which was presented at a gala event last month.

July 5, 2011

Shire has filed patent infringement suits against two generic drug makers relating to its attention deficit hyperactivity disorder treatment.

DUBLIN — Shire has filed patent infringement suits against two generic drug makers relating to its attention deficit hyperactivity disorder treatment.

Shire said it has filed lawsuits in the U.S. District Court for the District of New Jersey against Amneal Pharmaceuticals and Sandoz. Amneal and Sandoz recently filed abbreviated new drug applications with the Food and Drug Administration to market generic Vyvanse (lisdexamfetamine), an ADHD drug.

June 20, 2011

A generic drug maker has been granted approval from the Food and Drug Administration to manufacture its version of a urinary tract infection treatment.

SUPPLIER NEWS — A generic drug maker has been granted approval from the Food and Drug Administration to manufacture its version of a urinary tract infection treatment. Amneal Pharmaceuticals said that its nitrofurantoin oral suspension in the 25-mg/5-mL strength is the first-to-market generic version of Furadantin, made by Shionogi Pharma. Amneal will sell its generic in 8-oz. (230-mL) size bottles, the company said. Annual U.S. sales of nitrofurantoin oral suspension totaled $40 million for the year ended in January, according to IMS Health data.


May 23, 2011

A generic drug maker has been granted approval from the Food and Drug Administration to manufacture its version of a urinary tract infection treatment.

BRIDGEWATER, N.J. — A generic drug maker has been granted approval from the Food and Drug Administration to manufacture its version of a urinary tract infection treatment.

Amneal Pharmaceuticals said that its nitrofurantoin oral suspension in the 25-mg/5-mL strength is the first-to-market, AB-rated, generic version of Furadantin, which is made by Shionogi Pharma.

Amneal will sell its generic in 8-oz./230-mL size bottles, the company said.

March 3, 2011

The Food and Drug Administration has approved a generic drug for pain and inflammatory diseases made by Amneal Pharmaceuticals, Amneal said Thursday.

BRIDGEWATER, N.J. — The Food and Drug Administration has approved a generic drug for pain and inflammatory diseases made by Amneal Pharmaceuticals, Amneal said Thursday.

The FDA approved indomethacin extended-release capsules in the 75-mg strength. The drug is used to treat pain associated with rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, bursitis and tendonitis.