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DAYTON, N.J. — Aurobindo Pharma Ltd. this week announced Food and Drug Administration clearance for a pair of new generic drugs, including women’s health and antacid products.
On Wednesday, Aurobindo said it has received FDA approval for norethindrone acetate tablets 5 mg, a generic equivalent of Aygestin tablets from Duramed Pharmaceuticals.
Norethindrone acetate tablets are indicated for the treatment of secondary amenorrhea, endometriosis and abnormal uterine bleeding. The product totaled U.S. sales of $23.7 million for the 12 months through November 2015, according to IMS Health data cited by Aurobindo.
On Monday, Aurobindo announced FDA approval of famotidine tablets 20 mg and 40 mg, a generic version of Pepcid tablets from Valeant Pharmaceuticals International Inc.
Famotidine tablets are used for the short-term treatment of an active duodenal ulcer, an active benign gastric ulcer and gastroesophageal reflux disease (GERD). The stomach acid reducing medication also is used for maintenance therapy for duodenal ulcer patients at reduced dosage after the healing of an active ulcer, as well as for the treatment of pathological hypersecretory conditions, such as Zollinger-Ellison Syndrome and multiple endocrine adenomas, Aurobindo said.
For the 12 months through November 2015, famotidine tablets (20 mg and 40 mg) had U.S sales of $44.8 million, according to IMS figures reported by Aurobindo.
