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).
Hikma, Sciecure Pharma ink deal for niche injectable anti-viral medicines
Hikma Pharmaceuticals has reached a license, supply and distribution agreement between its wholly-owned subsidiary Hikma Pharmaceuticals International and Beijing Sciecure Pharmaceutical, a leading Chinese company that researches, develops and manufactures pharmaceutical products for global markets.
The agreement provides Hikma with exclusive rights to sell one of Sciecure’s niche injectable anti-viral medicines across the U.S. for a minimum of eight years, with an option to extend this partnership for an additional two years.
Sciecure expects to file this product for approval with the US Food and Drug Administration in early 2019.
“We are thrilled to partner with Sciecure, an innovative and vertically integrated company capable of producing high-quality products across the pharmaceutical spectrum from API to finished doses,” Hikma executive vice president of commercial and business development Daniel Motto said. “Our partnership with Sciecure is another example of how Hikma is continuing to expand its pipeline, targeting both niche products and high-volume opportunities, in order to offer a broad portfolio of high-quality medicines to US patients, physicians and hospitals.”