fda-approval-letter
PHARMACY

Pliaglis’ ‘Not for Home Use’ label restriction gets green lighted

BY Sandra Levy

Crescita Therapeutics has received the green light from the Food and Drug Administration for removal of the “Not for Home Use” label restriction for Pliaglis.

“We are delighted with the approval of this label change by the FDA. It marks a significant milestone as it will expand the ability of patients to have access to the drug and will facilitate our partner’s efforts to increase market acceptance of Pliaglis in the U.S.,” Cresctia president and CEO, Serge Verreault said.

Pliaglis, a lidocaine and tetracaine (7%/7%) formulation, is a topical local anesthetic cream that provides safe and effective local dermal anesthesia on intact skin prior to superficial dermatological procedures, such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing and laser-assisted tattoo removal, according to the company.

Taro launched the product in the United States in the first quarter of 2018.

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PHARMACY

Braeburn’s Brixadi gets tentative approval

BY Sandra Levy

Camurus’ U.S. partner, Braeburn has received tentative approval from the Food and Drug Administration for Brixadi (buprenorphine) extended-release injection for subcutaneous use, in 8 mg, 16 mg, 24 mg, 32 mg (weekly) and 64 mg, 96 mg, 128 mg (monthly) dosage strengths.

The product is for the treatment of moderate-to-severe opioid use disorder, or OUD in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine.

“Braeburn remains committed to take appropriate actions with a goal of providing US patients with OUD rapid access to a much needed, innovative long-acting treatment with flexible individualized dosing and potential to reduce the detrimental impacts of the ongoing opioid crisis,” Camurus president and CEO, Fredrik Tiberg said. “The US tentative approval follows closely after the regulatory approvals of our weekly and monthly buprenorphine depots, Buvidal, in Europe and Australia and provides additional validation of our innovative FluidCrystal technology.”

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PHARMACY

Alembic gets approval for 2 generics

BY Sandra Levy

Alembic Pharmaceuticals has received the Food and Drug Administration’s nod for pramipexole dihydrochloride ER tablets in 0.375-mg, 0.75-mg, 1.5-mg, 2.25-mg, 3 mg, 3.75-mg and 4.5-mg dosage strengths.

The product, which is the generic of Boehringer lngelheim’s Mirapex ER tablets, is indicated for the treatment of Parkinson’s disease.

Pramipexole dihydrochloride ER tablets had a market value of roughly $38.6 million for the 12 months ending December 2017, according to IQVIA.

Alembic also received the FDA’s approval for olopatadine hydrochloride ophthalmic solution 0.1 %.

The product, which is the generic of Novartis’ Patanol ophthalmic solution 0.1 %, is indicated for the treatment of the signs and symptoms of allergic conjunctivitis.

Olopatadine hydrochloride ophthalmic solution had a market value of about $61 million for the 12 months ending December 2017, according to IQVIA.

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