Sun Pharma gets FDA nod for Cequa’s dry eye treatment
Sun Pharmaceutical Industries has received the FDA green light for Cequa (cyclosporine ophthalmic solution) 0.09%, it announced Thursday.
Cequa is indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye)and is the first and only approved CsA product that incorporates a nanomicellar technology, according to the company.
The nanomicellar formulation allows the CsA molecule to overcome solubility challenges, penetrate the eye’s aqueous layer and prevents the release of the active lipophilic molecule prior to penetration.
“Dry eye disease represents an area of high unmet medical need, with a significant number of patients who are currently untreated,” Sun Pharma CEO North America Abhay Gandhi, said in a press statement. “The U.S. FDA approval of Cequa represents a long-awaited dry eye treatment option and is an important milestone in the development of Sun’s ophthalmics business. CEQUA, with its novel nanomicellar formulation for a proven dry eye medication, delivers a lipophilic molecule in a clear solution form.”
The product will be commercialized by Sun Ophthalmics, the branded ophthalmics division of Sun Pharma’s wholly owned subsidiary.
Teva gets FDA clearance for first EpiPen generics
The Food and Drug Administration has approved the first generic of Mylan’s EpiPen and EpiPen Jr. The FDA granted its approval to Teva for its 0.3- and 0.15-mg strength epinephrine auto-injectors for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds.
“Today’s approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval,” FDA commissioner Scott Gottlieb, said, in a press statement. “This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages.”
Anaphylaxis is a medical emergency that affects the whole body and, in some cases, leads to death. This epinephrine injection (auto-injector) is intended for immediate administration to patients. When given intramuscularly or subcutaneously, it has a rapid onset and short duration of action. Epinephrine works by reducing swelling in the airway and increasing blood flow in the veins.
The EpiPen is intended to automatically inject a dose of epinephrine into a person’s thigh to stop an allergic reaction.
The FDA has approved several epinephrine auto-injector products under new drug applications to treat anaphylaxis, including EpiPen, Adrenaclick and Auvi-Q. In addition, authorized generic versions of EpiPen and Adrenaclick are marketed without the brand names.
An authorized generic is made under the brand name’s existing new drug application using the same formulation, process and manufacturing facilities that are used by the brand name manufacturer. The labeling or packaging is, however, changed to remove the brand name or other trade dress. In some cases, a company may choose to sell an authorized generic at a lower cost than the brand-name drug product.
CVS Health addresses Ohio Medicaid pricing requirements
CVS Health has issued a statement saying it is actively working with its Ohio Managed Medicaid clients to restructure its contracts to implement the Ohio Department of Medicaid’s new “pass-through” pricing model requirement, effective January 1, 2019.
“Contrary to an inaccurate news report in The Columbus Dispatch, which was later picked up on social media, the pharmacy benefit managers (PBMs) servicing Ohio’s Managed Medicaid Plans have not been “fired,” the company said, in a statement. “PBMs have saved Ohio taxpayers $145 million annually through the services they provide to the state’s Medicaid managed care plans. CVS Health will continue to help its Ohio Medicaid clients manage their drug costs and improve their members’ health outcomes in 2019 and beyond.”