FDA grants tentative approval to two Sun generics
MUMBAI, India — The Food and Drug Administration has given tentative approval to two generic diabetes drugs made by Sun Pharmaceutical Industries, the Indian drug maker said.
Sun announced the tentative approvals for sitagliptin tablets in the 25 mg, 50 mg and 100 mg strengths and metformin hydrochloride extended-release tablets in the 500 mg and 1,000 mg strengths. The drugs are respectively generic versions of Merck's Januvia and Santarus' Glumetza.
Tentative approval means that the drugs meet the FDA's requirements for approval, but the agency can't give full approval because the brand-name drugs' patents haven't yet expired. Patents covering Januvia are scheduled to expire starting in April 2017, while those covering Glumetza are expected to expire starting in September 2016, according to FDA records.
Sitagliptin tablets have annual sales of about $2.7 billion, while metformin hydrochloride extended-release tablets have sales of about $140 million, according to Sun.