Aurobindo Pharma Limited announced that the company has received final approval from the U.S. Food and Drug Administration (FDA) to manufacture and market norethindrone acetate tablets (5 mg) in the United States. The tablets are used to treat endometriosis, uterine bleeding caused by abnormal hormone levels, and secondary amenorrhea.

The approved Abbreviated New Drug Application (ANDA) is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Aygestin Tablets, 5 mg, of Duramed Pharmaceuticals. Aurobindo says this FDA approval is the 57th ANDA to be approved out of the company’s Unit VII formulation facility in Hyderabad, India, for manufacturing oral non-antibiotic products.

A 2012 paper titled “Use of Norethindrone Acetate Alone for Postoperative Suppression of Endometriosis Symptoms” (J Pediatr Adolesc Gynecol. 2012 Apr;25(2):105-8. DOI: http://dx.doi.org/10.1016/j.jpag.2011.09.013), co-authored by a team of gynecology specialists affiliated with the Division of Gynecology at Children’s Hospital Boston, Massachusetts, and published in the Journal of Pediatric and Adolescent Gynecology, evaluated the efficacy and tolerability of norethindrone acetate (NA) as single-agent hormonal therapy for the suppression of endometriosis symptoms in adolescents and young adults.

The researchers — D.J. Kaser, MD; S.A. Missmer, ScD; K.F. Berry, MA; and corresponding author M.R. Laufer — conducted an electronic medical records search of all women treated by one gynecologist (M.R.L.) from 1992 to 2010. An IRB-approved chart review was then conducted on the index records of patients who received continuous treatment with NA (5–15 mg daily). Main outcome measures surveyed included postoperative bleeding and pain scores, and adverse effects.

The authors reported that 194 patients (median age, 18.9 years) with surgically diagnosed endometriosis initiated NA treatment postoperatively during the study period. Ninety-two percent of the patients had stage 1 or 2 disease, and distribution was similar among those excluded. Median pain scores decreased from 5 at NA initiation to 0 at follow-up, and bleeding scores diminished from 2 to 0, respectively, for all stages of endometriosis. Post-NA bleeding scores were improved regardless of prior hormonal regimen, and post-NA pain scores improved in all patients except for those previously prescribed Gonadotropin releasing hormone (GnRH) agonist plus add-back. Most patients (55.2%) did not report any side effects, with the most common adverse effect cited by those who did being weight gain (16.1%), with a mean increase in BMI of 1.2–1.6 kg/m2 at 12 months.

Based on the data, the investigators concluded that NA alone is a well-tolerated, effective option to manage pain and bleeding for all stages of endometriosis, and among those on prior hormonal therapy, symptoms improved after NA initiation.

Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy, and a small group of other professionals, Aurobindo Pharma commenced operations in 1988-89 with a single unit manufacturing semi-synthetic penicillin (SSP) in Pondicherry, India. The company went public in 1992, and listed its shares on the Indian stock exchanges in 1995. The company has a presence in a range of therapeutic segments, including neurosciences, cardiovascular, anti-retrovirals, anti-diabetics, gastroenterology and cephalosporins, among others. Aurobindo Pharma also entered the specialty generic formulations sector, and has evolved into a R&D-focused company with a multiproduct portfolio, with manufacturing facilities in several countries.

Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients, with a product portfolio spread over six therapeutic/product categories — antibiotics, anti-retrovirals, CVS, CNS, gastroenterologicals, and anti-allergies — which it markets globally.

Sources:
Aurobindo Pharma Limited
Journal of Pediatric and Adolescent Gynecology
US Food & Drug Administration (USFDA)