News Briefs

05/06/2022

FDA gives Lupin clearance for 2 generics

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Binder with FDA Approved

The Food and Drug Administration has given Lupin permission for two new generics.

The FDA approved Iloperidone tablets, a generic of Vanda’s Fanapt tablets, in dosage strengths of 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg.

Fanapt is used for the treatment of schizophrenia in adults and will be manufactured at Lupin's facility in Goa, India.

Iloperidone tablets had a market value of roughly $162 million, according to March 2022 IQVIA data.

Lupin also received the FDA’s clearance for pregabalin capsules in dosage strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg.

The medication is the generic of Upjohn’s Lyrica, which is indicated to treat fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain and pain after shingles in adult patients, as well as partial-onset seizures in patients aged 1 month old and older with epilepsy who take one or more other drugs for seizures.

The product will be manufactured at Lupin's facility in Aurangabad, India.

Pregabalin capsules had a market value of approximately $263 million, according to IQVIA March 2022 data.

 

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05/06/2022

Alembic receives FDA nod for generic Abreva

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Stamp saying approved

Patients with cold sore/fever blisters on their face or lips will soon have a new generic treatment. 

Alembic Pharmaceuticals’ subsidiary Aleor Dermaceuticals has received the Food and Drug Administration clearance for its generic Docosanol cream.

The product is the generic of GlaxoSmithKline Consumer Healthcare’s Abreva cream 10% (OTC).

Docosanol cream 10% (OTC) has a market value of roughly $60 million for the 12 months ending December 2021, according to IQVIA.

05/06/2022

One Brands rolls out rocky road-inspired protein bar

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one brands rocky road

One Brands has a brand-new limited-edition protein bar variety that was inspired by a classic ice cream flavor.

The Boulder, Colo.-based company’s new rocky road-flavored bars contain a chocolatey center filled with almonds and marshmallow-flavored bits surrounded by a decadent icing-like coating, according to the brand.

“Summer and ice cream go hand in hand, and One is making it easy to enjoy the delicious flavor of rocky road in a convenient bar that includes 20 g of protein and only 1 g of sugar,” said Eric Clawson, One general manager. “One Brands is known for flavor innovation, and our proprietary blends not only capture the best flavors from cinnamon roll to chocolate brownie, but our soft, not chalky, bar texture is the reason to believe you can really have your sweets and protein too.”

Available for a limited time, One Brands’ rocky road bar can be found online at one1brands.com and Amazon.com, as well as in stores at The Vitamin Shoppe and Circle K among others.

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05/05/2022

Xiromed intros progesterone i​​​​​​​njection

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Injectables

Xiromed, the New Jersey-based generic division of Insud Pharmaceuticals — a global pharmaceutical group headquartered in Madrid, Spain — is offering progesterone injection 500 mg/10 ml (50 mg/ml) in a multiple-dose vial.

The medication is the generic of progesterone injection, which is used to restore normal menstrual periods (amenorrhea) or treat abnormal bleeding due to low hormone levels.

Progesterone injection 50 mg/ml and its generics had a market value of $20.4 million for the 12-month period ending February 2022, according to IQVIA.   

“This is Xiromed’s second U.S. product launch from our dedicated hormonal injectable facility, Laboratorios Farmalan, located in Leon, Spain,” said Donna Genova, senior vice president of sales and commercial operations. “Xiromed continues to execute on our strategy to bring a robust portfolio of hormonal injectable products to the U.S. market.”

05/05/2022

Kellogg’s Frosted Flakes celebrates ‘Obi-Wan Kenobi’ premiere with limited-edition cereal

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frosted flakes obi wan kenobi cereal

Just weeks before the premiere of the “Obi-Wan Kenobi” series on Disney+, Kellogg’s Frosted Flakes joined forces with Lucasfilm on the launch of a new limited-edition cereal.

The new Kellogg’s Frosted Flakes Obi-Wan Kenobi cereal reflects the series’ dark and light side with a combination of the brand’s chocolate and classic flavors.

“For decades, ‘Star Wars’ has united fans across generations for movie nights, and we look forward to doing the same at the breakfast table with the release of our new Kellogg’s Frosted Flakes Obi-Wan Kenobi cereal,” said Sadie Garcia, director of brand marketing at Kellogg All Family Cereal.

In addition, the packaging even features Tony the Tiger sporting his best Obi-Wan Kenobi and Darth Vader attire in honor of the upcoming series, which premieres on May 27 on the streaming platform.

Kellogg’s Frosted Flakes Obi-Wan Kenobi cereal will be available at retailers nationwide beginning in July at the suggested retail price of $4.29 for a 10.7-oz. box and $5.29 for a 17.1-oz. box.

05/04/2022

Supernus obtains FDA nod for new indication of Qelbree

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Binder with FDA Approved

Supernus Pharmaceuticals, a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, has received the Food and Drug Administration’s blessing for an expanded indication of Qelbree (viloxazine extended-release capsules) for the treatment of attention deficit hyperactivity disorder in adult patients aged 18 years old and older.

Qelbree is now approved for the treatment of ADHD in children, starting at age 6 years old, adolescents and adults.

“Until today, nonstimulant ADHD options for adults have been very limited,” said Greg Mattingly, founding partner of St. Charles Psychiatric Associates in St. Louis. “This approval is positive news and offers a new novel option for the millions of American adults who are trying to find the right treatment to manage their ADHD symptoms.”

Approximately 16 million children, adolescents and adults have ADHD in the United States. While many children with ADHD outgrow it, up to 90% of those diagnosed with ADHD in childhood continue to have ADHD as adults, the company noted.

“As a leader in the field of CNS, we are fully committed to better understanding how to treat complex diseases such as ADHD,” said Jack Khattar, president and CEO of Supernus Pharmaceuticals.

“Today’s approval marks a major advancement in the treatment of ADHD and is an important milestone just one year after the approval of Qelbree to treat pediatric patients,” Khattar said. We are proud to bring a new novel nonstimulant option for adults into the market after two decades.”