Sun Pharma Advanced Research Company today said the US health regulator has not approved its new drug application for Xelpros, a preservative-free eye drop.
Jubilant Cadista Pharmaceuticals Inc, part of the Jubilant Group, is recalling over 1,500 bottles of glucocorticoid Methylprednisolone tablets in the US market due to incorrect labelling.
As per the FDA, a class III recall is initiated in "a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
"Tricor tablets and generic equivalents had US sales of approximately $307 million for the 12-month period ending October 2016, according to IMS Health," Cipla said.
Homegrown pharma major Lupin Ltd on Monday announced the launch of generic version of its voriconazole tablets and oral suspension used for treatment of fungal infectinos in children.
Currently, Ocular is developing Seciera for treating dry eye disease, the city-based company said, adding the drug is currently in Phase-3 confirmatory clinical trials.
Claris Injectables manufactures and markets generic injectables across multiple delivery systems, markets and therapeutic segment including anesthesia, anti-infectives and others.
The Mumbai-based pharmaceuticals company said the US health regulator had conducted an inspection at the Ankleshwar facility from December 5 to December 9.
Alkem Laboratories said it will put together a detailed response with adequate corrective and preventive measures to address the FDA's observations and the same is proposed to be filed within the time line stipulated by the US regulator.
In August this year, Natco Pharma received a final approval for its abbreviated new drug application for generic versions of Tamiflu oral capsules from the US drug regulator.
