Zydus Cadila obtains 2 FDA approvals, 1 tentative

Zydus Cadila has received two approvals from the Food and Drug Administration, one of them tentative.

Zydus has obtained full approval from the Food and Drug Administration for dimethyl fumarate delayed release capsules, in dosage strengths of 120 mg and 240 mg. The product is used to treat patients with relapsing forms of multiple sclerosis.

Zydus was one of the first ANDA applicants to submit a substantially complete ANDA and is therefore eligible for 180 days of generic drug exclusivity along with other first ANDA applicants, the company said.

The FDA granted approval following entry of judgment in favor of Zydus Cadila and other ANDA applicants by the U.S. District Court for the District of Delaware, holding that the only unexpired patent covering Tecfidera is invalid, the company said.

The product will be manufactured at the group’s manufacturing facility at SEZ, Matoda.

Zydus Cadila has received tentative approval from the FDA for palbociclib capsules in dosage strengths of 75 mg, 100 mg and 125 mg.

The product is the generic of Pfizer’s Ibrance capsules.

Palbociclib is an anti-cancer medicine that interferes with the growth and spread of cancer cells in the body. It is used in adults to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic) in combination with an aromatase inhibitor as the first hormonal based therapy in postmenopausal women or in men, or fulvestrant with disease progression following hormonal therapy.

The drug will be manufactured at the group’s formulation manufacturing facility at SEZ, Ahmedabad.