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glenmark pharmaceuticals inc., usa - abiraterone acetate (unii: em5ocb9yj6) (abiraterone - unii:g819a456d0) - abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with none. risk summary the safety and efficacy of abiraterone acetate have not been established in females. based on findings from animal studies and the mechanism of action, abiraterone acetate can cause fetal harm and potential loss of pregnancy. there are no human data on the use of abiraterone acetate in pregnant women. in animal reproduction studies, oral administration of abiraterone acetate to pregnant rats during organogenesis caused adverse developmental effects at maternal exposures approximately ≥ 0.03 times the human exposure (auc) at the recommended dose (see data). data animal data in an embryo-fetal developmental toxicity study in rats, abiraterone acetate caused developmental toxicity when administered at oral doses of 10, 30 or 100 mg/kg/day throughout the period of organogenesis (gestational days 6 to 17). findings included embryo-fetal lethality (increased post implantation loss and resorptions and decreased number of live fetuses), fetal developmental delay (skeletal effects) and urogenital effects (bilateral ureter dilation) at doses ≥ 10 mg/kg/day, decreased fetal ano-genital distance at ≥ 30 mg/kg/day, and decreased fetal body weight at 100 mg/kg/day. doses ≥ 10 mg/kg/day caused maternal toxicity. the doses tested in rats resulted in systemic exposures (auc) approximately 0.03, 0.1 and 0.3 times, respectively, the auc in patients. risk summary the safety and efficacy of abiraterone acetate have not been established in females. there is no information available on the presence of abiraterone in human milk, or on the effects on the breastfed child or milk production. contraception males based on findings in animal reproduction studies and its mechanism of action, advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 weeks after the final dose of abiraterone acetate [see use in specific populations (8.1)]. infertility based on animal studies, abiraterone acetate may impair reproductive function and fertility in males of reproductive potential [see nonclinical toxicology (13.1)]. safety and effectiveness of abiraterone acetate in pediatric patients have not been established. of the total number of patients receiving abiraterone acetate in randomized clinical trials, 70% of patients were 65 years and over and 27% were 75 years and over. no overall differences in safety or effectiveness were observed between these elderly patients and younger patients. other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. the pharmacokinetics of abiraterone were examined in subjects with baseline mild (n=8) or moderate (n=8) hepatic impairment (child-pugh class a and b, respectively) and in 8 healthy control subjects with normal hepatic function. the systemic exposure (auc) of abiraterone after a single oral 1,000 mg dose of abiraterone acetate increased by approximately 1.1-fold and 3.6-fold in subjects with mild and moderate baseline hepatic impairment, respectively compared to subjects with normal hepatic function. in another trial, the pharmacokinetics of abiraterone were examined in subjects with baseline severe (n=8) hepatic impairment (child-pugh class c) and in 8 healthy control subjects with normal hepatic function. the systemic exposure (auc) of abiraterone increased by approximately 7-fold and the fraction of free drug increased 2-fold in subjects with severe baseline hepatic impairment compared to subjects with normal hepatic function. no dosage adjustment is necessary for patients with baseline mild hepatic impairment. in patients with baseline moderate hepatic impairment (child-pugh class b), reduce the recommended dose of abiraterone acetate to 250 mg once daily. do not use abiraterone acetate in patients with baseline severe hepatic impairment (child-pugh class c). if elevations in alt or ast > 5 × uln or total bilirubin > 3 × uln occur in patients with baseline moderate hepatic impairment, discontinue abiraterone acetate treatment [see dosage and administration (2.4) and clinical pharmacology (12.3)]. for patients who develop hepatotoxicity during treatment, interruption of treatment and dosage adjustment may be required [see dosage and administration (2.4), warnings and precautions (5.3), and clinical pharmacology (12.3)]. no dosage adjustment is necessary for patients with renal impairment [see clinical pharmacology (12.3)].

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glenmark pharmaceuticals, inc - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 100 mg in 5 ml - oxycodone hydrochloride oral solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, [see warnings and precautions (5.2)], reserve oxycodone hydrochloride oral solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: oxycodone hydrochloride oral solution is contraindicated in patients with: risk summary prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.4)]. available data with oxycodone hydrochloride oral solution are insufficient to inform a drug-associated risk for major birth defects and miscarriage. animal reproduction studies with oral administrations of oxycodone hydrochloride in rats and rabbits during the period of organogenesis at doses 2.6 and 8.

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glenmark therapeutics inc., usa - citalopram hydrobromide (unii: i1e9d14f36) (citalopram - unii:0dhu5b8d6v) - citalopram tablets are indicated for the treatment of major depressive disorder (mdd) in adults [see clinical studies (14)] . citalopram tablets are contraindicated in patients: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants. risk summary based on data from published observational studies, exposure to ssris, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see warnings and precautions ( 5.4) and clinical considerations] . available data from published epidemiologic studies and postmarketing reports with citalopram use in pregnancy have not established an increased risk of major birth defects

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glenmark pharmaceuticals inc., usa - linezolid (unii: isq9i6j12j) (linezolid - unii:isq9i6j12j) - linezolid 600 mg - linezolid tablets are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. linezolid tablets are not indicated for the treatment of gram-negative infections. it is critical that specific gram-negative therapy be initiated immediately if a concomitant gram-negative pathogen is documented or suspected [see warnings and precautions (5.4) ]. nosocomial pneumonia caused by staphylococcus aureus (methicillin-susceptible and -resistant isolates) or streptococcus pneumoniae [see clinical studies (14) ]. community-acquired pneumonia caused by streptococcus pneumoniae , including cases with concurrent bacteremia, or staphylococcus aureus (methicillin-susceptible isolates only) [see clinical studies (14) ]. complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis , caused by staphylococcus aureus (methicillin-susceptible and -resistant isolates), streptococcus py

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glenmark pharmaceuticals inc., usa - nizatidine (unii: p41pml4ghr) (nizatidine - unii:p41pml4ghr) - nizatidine 150 mg - nizatidine capsules usp are indicated for up to 8 weeks for the treatment of active duodenal ulcer. in most patients, the ulcer will heal within 4 weeks. nizatidine capsules usp are indicated for maintenance therapy for duodenal ulcer patients at a reduced dosage of 150 mg h.s. after healing of an active duodenal ulcer. the consequences of continuous therapy with nizatidine for longer than 1 year are not known. nizatidine capsules usp are indicated for up to 12 weeks for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to gerd. nizatidine capsules usp are indicated for up to 8 weeks for the treatment of active benign gastric ulcer. before initiating therapy, care should be taken to exclude the possibility of malignant gastric ulceration.

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preferred pharmaceuticals inc. usa - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone tablets are indicated for the treatment of insomnia. in controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. the clinical trials performed in support of efficacy were up to 6 months in duration. the final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). risk summary available pharmacovigilance data with eszopiclone use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies conducted in pregnant rats and rabbits throughout organogenesis, there was no evidence of teratogenicity. administration of eszopiclone to rats throughout pregnancy and lactation resulted in offspring toxicities at all doses tested; the lowest dose wa

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glenmark pharmaceuticals inc., usa - lithium carbonate (unii: 2bmd2gna4v) (lithium cation - unii:8h8z5uer66) - lithium carbonate 450 mg - lithium carbonate extended-release tablets are indicated in the treatment of manic episodes of manic-depressive illness. maintenance therapy prevents or diminishes the intensity of subsequent episodes in those manic-depressive patients with a history of mania. typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness and possibly hostility. when given to a patient experiencing a manic episode, lithium carbonate extended-release tablets may produce a normalization of symptomatology within 1 to 3 weeks.

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glenmark pharmaceuticals inc., usa - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - norethindrone acetate 5 mg - norethindrone acetate is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. norethindrone acetate is not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.

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glenmark pharmaceuticals inc., usa - mometasone furoate (unii: 04201gdn4r) (mometasone - unii:8hr4qj6dw8) - mometasone furoate ointment, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older. mometasone furoate ointment is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. teratogenic effects: there are no adequate and well-controlled studies in pregnant women. therefore, mometasone furoate ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. when administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. the doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification. mometasone furoate also caused dystocia and related complications when administered to rats during the end of pregnancy. in mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above. fetal survival was reduced at 180 mcg/kg. no toxicity was observed at 20 mcg/kg. (doses of 20, 60, and 180 mcg/kg in the mouse are approximately 0.01, 0.02, and 0.05 times the estimated maximum clinical topical dose from mometasone furoate ointment on a mcg/m2 basis.) in rats, mometasone furoate produced umbilical hernias at topical doses of 600 mcg/kg and above. a dose of 300 mcg/kg produced delays in ossification, but no malformations. (doses of 300 and 600 mcg/kg in the rat are approximately 0.2 and 0.4 times the estimated maximum clinical topical dose from mometasone furoate ointment on a mcg/m2 basis.) in rabbits, mometasone furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical doses of 150 mcg/kg and above (approximately 0.2 times the estimated maximum clinical topical dose from mometasone furoate ointment on a mcg/m2 basis). in an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly and domed head) at 700 mcg/kg. at 2800 mcg/kg most litters were aborted or resorbed. no toxicity was observed at 140 mcg/kg. (doses of 140, 700, and 2800 mcg/kg in the rabbit are approximately 0.2, 0.9, and 3.6 times the estimated maximum clinical topical dose from mometasone furoate ointment on a mcg/m2 basis.) when rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, 15 mcg/kg caused prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival. similar effects were not observed at 7.5 mcg/kg. (doses of 7.5 and 15 mcg/kg in the rat are approximately 0.005 and 0.01 times the estimated maximum clinical topical dose from mometasone furoate ointment on a mcg/m2 basis.) systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. it is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. because many drugs are excreted in human milk, caution should be exercised when mometasone furoate ointment is administered to a nursing woman. mometasone furoate ointment may be used with caution in pediatric patients 2 years of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established. since safety and efficacy of mometasone furoate ointment have not been established in pediatric patients below 2 years of age, its use in this age group is not recommended. mometasone furoate ointment caused hpa axis suppression in approximately 27% of pediatric subjects ages 6 to 23 months, who showed normal adrenal function by cortrosyn test before starting treatment, and were treated for approximately 3 weeks over a mean body surface area of 39% (range 15% to 99%).the criteria for suppression were: basal cortisol level of ≤5 mcg/dl, 30-minute post-stimulation level of ≤18 mcg/dl, or an increase of <7 mcg/dl. follow-up testing 2 to 4 weeks after stopping treatment, available for 8 of the subjects, demonstrated suppressed hpa axis function in 3 subjects, using these same criteria. long-term use of topical corticosteroids has not been studied in this population [see clinical pharmacology (12.2)] . because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of hpa axis suppression and cushing’s syndrome when they are treated with topical corticosteroids. they are, therefore, also at greater risk of glucocorticosteroid insufficiency during and/or after withdrawal of treatment. pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids. pediatric patients applying topical corticosteroids to greater than 20% of body surface are at higher risk of hpa axis suppression. hpa axis suppression, cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to acth stimulation. manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. mometasone furoate ointment should not be used in the treatment of diaper dermatitis. clinical trials of mometasone furoate ointment included 310 subjects who were 65 years of age and over and 57 subjects who were 75 years of age and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger subjects. however, greater sensitivity of some older individuals cannot be ruled out.

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glenmark pharmaceuticals inc., usa - mometasone furoate (unii: 04201gdn4r) (mometasone - unii:8hr4qj6dw8) - mometasone furoate topical solution, 0.1% (lotion) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older. mometasone furoate topical solution is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. there are no adequate and well-controlled studies in pregnant women. therefore, mometasone furoate topical solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. when administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. the doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification. mometasone furoate also caused dystocia and related complications when administered to rats during the end of pregnancy. in mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above. fetal survival was reduced at 180 mcg/kg. no toxicity was observed at 20 mcg/kg (doses of 20, 60, and 180 mcg/kg in the mouse are approximately 0.01, 0.02, and 0.05 times the estimated maximum clinical topical dose from mometasone furoate topical solution on a mcg/m2 basis). in rats, mometasone furoate produced umbilical hernias at topical doses of 600 mcg/kg and above. a dose of 300 mcg/kg produced delays in ossification, but no malformations (doses of 300 and 600 mcg/kg in the rat are approximately 0.2 and 0.4 times the estimated maximum clinical topical dose from mometasone furoate topical solution on a mcg/m2 basis). in rabbits, mometasone furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical doses of 150 mcg/kg and above (approximately 0.2 times the estimated maximum clinical topical dose from mometasone furoate topical solution on a mcg/m2 basis). in an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly and domed head) at 700 mcg/kg. at 2800 mcg/kg most litters were aborted or resorbed. no toxicity was observed at 140 mcg/kg (doses at 140, 700, and 2800 mcg/kg in the rabbit are approximately 0.2, 0.9, and 3.6 times the estimated maximum clinical topical dose from mometasone furoate topical solution on a mcg/m2 basis). when rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, 15 mcg/kg caused prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival. similar effects were not observed at 7.5 mcg/kg (doses of 7.5 and 15 mcg/kg in the rat are approximately 0.005 and 0.01 times the estimated maximum clinical topical dose from mometasone furoate topical solution on a mcg/m2 basis). systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. it is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. because many drugs are excreted in human milk, caution should be exercised when mometasone furoate topical solution is administered to a nursing woman. since safety and efficacy of mometasone furoate topical solution have not been established in pediatric patients below 12 years of age, its use in this age group is not recommended. mometasone furoate topical solution caused hpa axis suppression in approximately 29% of pediatric subjects ages 6 to 23 months, who showed normal adrenal function by cortrosyn test before starting treatment, and were treated for approximately 3 weeks over a mean body surface area of 40% (range 16% to 90%). the criteria for suppression were: basal cortisol level of ≤5 mcg/dl, 30-minute post-stimulation level of ≤18 mcg/dl, or an increase of <7 mcg/dl. follow-up testing 2 to 4 weeks after stopping treatment, available for 8 of the subjects, demonstrated suppressed hpa axis function in 1 subject, using these same criteria. long-term use of topical corticosteroids has not been studied in this population [see clinical pharmacology ( error! hyperlink reference not valid. )] . because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of hpa axis suppression and cushing’s syndrome when they are treated with topical corticosteroids. they are, therefore, also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids. pediatric patients applying topical corticosteroids to greater than 20% of body surface are at higher risk of hpa axis suppression. hpa axis suppression, cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to acth stimulation. manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. mometasone furoate topical solution should not be used in the treatment of diaper dermatitis. clinical trials of mometasone furoate topical solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious usually starting at the low end of the dosing range.