fda-approval-letter
PHARMACY

FDA approved clobazam oral film formulation

BY Sandra Levy

Specialty pharmaceutical company Aquestive recently announced that it had received Food and Drug Administration approval for Sympazan — an oral film formulation of clobazam, which is indicated as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome, or LGS, in patients age 2 years old or older.

Previously, clobazam, which has the brand name Onfi, has only been available in tablet and oral suspension formulations. Sympazan is the first and only oral film that is FDA-approved to treat seizures associated with LGS, the company said.

Sympazan is berry flavored and is available in 5-, 10- and 20-mg dosages.

LGS is a severe form of epilepsy that begins in early childhood and is characterized by multiple types of seizures and intellectual disability. LGS patients often have difficulty swallowing pills and large volume suspensions due to physical limitations, behavioral or cognitive impact.

“Aquestive Therapeutics is pleased to bring Sympazan to the LGS community,” Aquestive Therapeutics CEO Keith Kendall said. “Treating LGS can be difficult; patients may have a hard time swallowing oral medications. We’re optimistic Sympazan can help address unmet medical needs and be an important treatment option for this patient population.”

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PHARMACY

Cumberland Pharmaceuticals to acquire Theravance Biopharma’s Vibativ

BY Sandra Levy

Specialty pharmaceutical company Cumberland Pharmaceuticals has reached an agreement to acquire Vibativ from Theravance Biopharma.

Vibatin (telavancin) is an anti-infective for the treatment of certain serious bacterial infections, including hospital-acquired and ventilator-associated bacterial pneumonia and complicated skin and skin structure infections. It addresses a range of gram-positive bacterial pathogens, including those that are considered difficult to treat and multidrug-resistant.

Cumberland will assume full responsibility for the product, including its marketing, distribution, manufacturing and regulatory activities.

“Vibativ is a lifesaving product for certain difficult to treat infections, and we are honored to be selected to acquire and transition the brand to our existing hospital acute care infrastructure,” Cumberland Pharmaceuticals CEO A.J. Kazimi said. Our immediate plan for Vibativ is to ensure a smooth transition of the product supply and medical support to current users of the brand. We will then launch our hospital promotion and medical initiatives to help ensure that the product is available to the patients who need it. We are very optimistic about the opportunity that Vibativ will offer Cumberland.”

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PHARMACY

Genoa Healthcare debuts 14 pharmacies

BY Sandra Levy

Genoa Healthcare, a provider of pharmacy, outpatient telepsychiatry and medication management services, has expanded with the opening of 14 pharmacies.

Genoa has opened in the following locations Laredo, Texas; Grants Pass, Ore.; Hannibal, Ore.; Lufkin, Texas; Weslaco, Texas; Toledo, Ohio; Valley Cottage, N.Y.; Biddeford, Maine; St. Louis Park, Minn.; Hartford, Conn; Eugene, Ore.; New Port Richey, Fla.; Tallahassee, Fla,; and Williamsburg, Va.

These new locations bring the total number of pharmacies opened this year to 51 for a total of 437 pharmacies.

“Genoa Healthcare is grateful to be working with our center partners in these communities to bring quality service to those struggling with behavioral and other complex health conditions,” the company said.

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