Braeburn’s Brixadi gets tentative approval
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.”
Alembic gets approval for 2 generics
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.
Sanofi, Merck get Vaxelis approval
Sanofi and Merck have received the Food and Drug Administration’s blessing for Vaxelis (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, haemophilus b conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine) for use in children from 6 weeks through 4 years of age, or prior to the 5th birthday.
Vaxelis was developed as part of a joint partnership between Sanofi and Merck.
Commercial supply will not be available in the United States prior to 2020.
Vaxelils is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday).